FDA 510(k) Applications for Medical Device Product Code "DQA"
(Oximeter)

FDA 510(k) Number Applicant Device Name Decision Date
K111617 ACARE TECHNOLOGY CO., LTD. PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 12/22/2011
K112465 ADVANCED INSTRUMENTS, INC. VITAL SIGNS MONITOR 09/14/2011
K001308 AGILENT TECHNOLOGIES MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW 05/17/2000
K080348 AIRSEP CORP. OXISCAN II DATA MANAGEMENT SYSTEM 10/09/2008
K010966 ALARIS MEDICAL SYSTEMS, INC. MEDLEY SP02 MODULE, MODEL 8220 06/08/2001
K022677 ALARIS MEDICAL SYSTEMS, INC. MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE 09/11/2002
K971828 ALEXANDER MFG. CO. ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115 08/12/1997
K971235 ALEXANDER MFG. CO. ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W 06/05/1997
K972786 ALEXANDER MFG. CO. ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366 10/17/1997
K971827 ALEXANDER MFG. CO. ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764 08/12/1997
K153021 AMEMO INC Fingertip Pulse Oximeter A310 11/22/2016
K052544 AMERICAN I.V. PRODUCTS, INC. PULSE OXIMETER ADAPTER CABLES 09/29/2006
K121697 ANDON HEALTH CO., LTD FINGERTIP PULSE OXIMETER 10/15/2012
K131111 ANDON HEALTH CO.,LTD IHEALTH FINGERTIP PULSE OXIMETER 09/11/2013
K082846 APK TECHNOLOGY CO., LTD APK SPO2 PULSE OXIMETER SENSOR 04/03/2009
K172981 APK Technology Co., Ltd. Reusable SpO2 Sensors, Disposable SpO2 Sensors 06/08/2018
K970769 ARISTO MEDICAL COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR 08/28/1997
K960251 ARISTO MEDICAL PRODUCTS, INC. COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR 03/26/1996
K160582 Athena GTX WiCap 09/02/2016
K101568 ATLANTEAN MODEL SB100II FINGER PULSE OXIMETER 09/20/2010
K962156 BCI INTL., INC. 3304 PULSE OXIMETER 08/28/1996
K991410 BCI INTL., INC. 3402 HANDHELD PULSE OXIMETER 06/09/1999
K981939 BCI INTL., INC. AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR 08/20/1998
K980714 BCI INTL., INC. BCI 3401 HANDHELD PULSE OXIMETER 03/25/1998
K963496 BCI INTL., INC. OXI TEMP 11/26/1996
K960058 BCI INTL., INC. OXITEMP, 3301T SA 05/15/1996
K013171 BCI, INC. 3420 DIGIT PULSE OXIMETER, MODEL 3420 01/03/2002
K013862 BCI, INC. BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM 02/21/2002
K020739 BCI, INC. BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR 06/03/2002
K020350 BCI, INC. BCI 3180 PULSE OXIMETER 04/30/2002
K011156 BCI, INC. BCI 3403 SLEEP SCREENING PULSE OXIMETER 06/14/2001
K031742 BCI, INC. BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER 08/18/2003
K001770 BCI, INC. BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A 07/05/2000
K181503 Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter 10/11/2018
K160268 BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. Fingertip Pulse Oximeter MD300CG11/MD300CG51 10/14/2016
K161560 BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. Fingertip Pulse Oximeter MD300CN310 10/05/2016
K220101 Beijing Choice Electronic Technology Co., Ltd. Pulse Oximeter 03/08/2023
K230172 Beijing Choice Electronic Technology Co., Ltd. Pulse Oximeter 08/12/2023
K211400 Beijing Choice Electronic Technology Co., Ltd. Pulse Oximeter 02/11/2022
K152563 BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. Pulse Oximeter (MD300M/MD300K2) 04/18/2016
K172366 Beijing Choice Electronic Technology Co., Ltd. Wrist Pulse Oximeter 03/16/2018
K141024 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. EXTERNAL PULSE OXIMETER 01/13/2015
K140682 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. FINGERTIP PULSE OXIMETER 07/17/2014
K141128 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. FINGERTIP PULSE OXIMETER 08/13/2014
K151206 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Fingertip Pulse Oximeter 08/28/2015
K131047 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. FINGERTIP PULSE OXIMETER 10/16/2013
K130947 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. FINGERTIP PULSE OXIMETER 10/03/2013
K142888 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Fingertip Pulse Oximeter 02/20/2015
K123871 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. FINGERTIP PULSE OXIMETER 05/10/2013
K070371 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. FINGERTIP PULSE OXIMETER MD300C 08/13/2007
K092652 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA 01/08/2010
K072825 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. FINGERTIP PULSE OXIMETER, MODEL MD300I 01/14/2008
K111494 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. HANDHELD PULSE OXIMETER 01/18/2012
K100203 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M 05/17/2010
K082487 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. M-50 SERIES SPO2 SENSOR 03/04/2009
K083466 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. MD2000A VITAL SIGN MONITOR, MODEL MD2000A 04/03/2009
K093757 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. MD300C1 FINGERTIP PULSE OXIMETER 03/03/2010
K092620 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. MD300C318 FINGERTIP PULSE OXIMETER 12/04/2009
K090599 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. MD300K1 PULSE OXIMETER 07/20/2009
K101577 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES 12/02/2010
K122046 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. WRIST PULSE OXIMETER 02/04/2013
K081125 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. WRIST PULSE OXIMETER MD300W 07/02/2008
K103685 BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD. PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA 07/15/2011
K172616 Beijing Safe Heart Technology Ltd. Pulse Oximeter 07/27/2018
K180174 Belun Technology Company Limited Belun Ring 05/29/2018
K191417 Belun Technology Company Limited Belun Ring 10/10/2019
K211407 Belun Technology Company Limited Belun Ring BLR-100X 10/21/2021
K003542 BETA BIOMED SERVICES, INC. PREAMP CABLE, MODEL B400-1011PA 04/06/2001
K011518 BETA BIOMED SERVICES, INC. VITALSAT SERIES 11/15/2002
K000814 BHS INTL., INC. FINGER PULSE METER 03/29/2001
K132516 BIO MEDICAL TECHNOLOGIES CO., LTD OXIPROBE E (OXIPROBE) 07/30/2014
K092549 BIO MEDICAL TECHNOLOGIES CO., LTD OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P 11/16/2009
K181006 Bio-Beat Technologies Ltd. BB-613 Watch Oximeter 09/21/2018
K971273 BIO-TEK INSTRUMENTS, INC. INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF 10/08/1997
K190792 BioBeat Technologies Ltd. BB-613WP 08/22/2019
K222010 BioBeat Technologies Ltd. Biobeat Platform-2 and BB-613WP Patch 12/30/2022
K212153 BioBeat Technologies Ltd. Biobeat Platform, BB-613WP Patch 03/25/2022
K162014 BLUEPOINT MEDICAL GMBH & CO. KG Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) 02/06/2017
K221361 BodiMetrics, LLC circulÖ pro Ring 08/29/2023
K954267 BURDICK, INC. BURDICK 200 PULSE OXIMETER 05/03/1996
K061706 CADWELL LABORATORIES, INC. CADWELL EASYNET OXIMETER MODULE 03/05/2007
K043162 CARD GUARD SCIENTIFIC SURVIVAL, LTD. PMP4 OXY PRO 12/29/2004
K142959 CAREFUSION GERMANY 234 GMBH Vyntus Walk 03/20/2015
K050844 CAS MEDICAL SYSTEMS, INC. 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL 06/23/2005
K982776 CAS MEDICAL SYSTEMS, INC. 9303 NEONATAL/ADULT VITAL SIGNS MONITOR 11/02/1998
K051257 CAS MEDICAL SYSTEMS, INC. ADULT CEREBRAL OXIMETER, MODEL 2040 12/22/2005
K073036 CAS MEDICAL SYSTEMS, INC. FORE-SIGHT, MC-2000 SERIES 02/25/2008
K083892 CAS MEDICAL SYSTEMS, INC. FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030) 03/19/2009
K980879 CAS MEDICAL SYSTEMS, INC. OSCILLOMATE NIBP / SP02 EMS MONITOR 07/16/1998
K092641 CHARMCARE CO., LTD CHARMCARE TABLETOP PULSE OXIMETER 10/21/2010
K220351 Chronisense Medical, Ltd. Polso Watch 11/18/2022
K083351 COMDEK INDUSTRIAL CORP. PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P 04/24/2009
K083448 CONMED CORPORATION CABLE, TRANSDUCER, MODEL 2400GN 08/20/2009
K061112 CONMED CORPORATION CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M 05/22/2006
K032831 CONMED CORPORATION PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 08/31/2004
K073454 CONTEC MEDICAL SYSTEM CO., LTD. FINGERTIP PULSE OXIMETER, MODEL CMS-50C 05/05/2008
K082641 CONTEC MEDICAL SYSTEM CO., LTD. FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL 11/10/2008
K090671 CONTEC MEDICAL SYSTEM CO., LTD. PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D 06/11/2009
K141362 CONTEC MEDICAL SYSTEMS CO., LTD. PULSE OXIMETER CMS50EW 04/23/2015
K130320 COVIDIEN BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW 02/04/2014
K121806 COVIDIEN BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE 09/28/2012
K083325 COVIDIEN N-600X WITH SPD, OXIMAX N-600X 03/09/2009
K141518 COVIDIEN Nellcor Bedside Respiratory Patient Monitoring System 03/05/2015
K172482 Covidien The Nellcor pulse oximetry monitor interface cable 12/15/2017
K201179 Covidien llc GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable 07/20/2020
K142865 Covidien LLC Nellcor Bedside SpO2 Patient Monitoring System 03/26/2015
K120773 Covidien LLC NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM 07/10/2012
K212555 Covidien llc Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC 05/06/2022
K141542 Covidien LLC NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) 10/02/2014
K123581 COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN 05/09/2013
K970061 DATASCOPE CORP. ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) 09/25/1997
K011670 DATEX-OHMEDA DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE 06/26/2001
K020479 DATEX-OHMEDA DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES 03/26/2002
K983684 DATEX-OHMEDA, INC. DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS 11/06/1998
K010463 DATEX-OHMEDA, INC. DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES 03/15/2001
K001688 DATEX-OHMEDA, INC. DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER 06/30/2000
K993512 DATEX-OHMEDA, INC. DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER 03/31/2000
K021955 DATEX-OHMEDA, INC. TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES 10/08/2002
K122927 DELBIO INCORPORATED OXICARE FINGERTIP PULSE OXIMETER 12/20/2012
K133090 DELBIO INCORPORATION OXICARE FINGERTIP PULSE OXIMETER 02/28/2014
K100020 DIXTAL MEDICAL INC. DX SERIES FINGER SENSOR 03/08/2010
K103285 DIXTAL MEDICAL, INC. DIXTAL DZ-4100 SERIES PULSE OXIMETER 07/25/2011
K060524 DOLPHIN MEDICAL INC. DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES 06/15/2006
K012989 DOLPHIN MEDICAL INC. DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 03/20/2002
K033876 DOLPHIN MEDICAL INC. DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 03/11/2004
K030952 DOLPHIN MEDICAL INC. DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421 05/19/2003
K030629 DOLPHIN MEDICAL INC. DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER 09/04/2003
K040380 DOLPHIN MEDICAL INC. DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 08/31/2004
K024235 DOLPHIN MEDICAL INC. DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER 03/17/2003
K021959 DOLPHIN MEDICAL INC. DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 07/11/2002
K031465 DOLPHIN MEDICAL INC. MODEL 2100 PULSE OXIMETER 10/10/2003
K020075 DOLPHIN MEDICAL INC. MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER 02/08/2002
K032947 DOLPHIN MEDICAL INC. NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 10/17/2003
K014218 DOLPHIN MEDICAL INC. OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' 11/07/2002
K210305 Dongguan Lingxin Technologies Co., LTD Pulse Oximeter 12/22/2021
K032537 Draeger Medical Systems, Inc. DRAEGER MICRO2+ AND MASIMO MINISAT 11/25/2003
K061329 Draeger Medical Systems, Inc. INFINITY MASIMO SET SP02 POD 07/07/2006
K082888 Draeger Medical Systems, Inc. INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 11/26/2008
K062724 EAGLE MEDICAL EQUIPMENT CO. ACCUPULSE PULSE OXIMETER 05/11/2007
K092727 EDAN INSTRUMENTS, INC. H100B PULSE OXIMETER 12/03/2009
K180380 Edan Instruments, Inc. vital signs monitor 12/21/2018
K083821 EDAN INSTRUMENTS, INC. VITAL SIGNS MONITOR 05/14/2009
K102835 EDAN INSTRUMENTS, INC. VITAL SIGNS MONITOR 12/27/2010
K131818 EDAN INSTRUMENTS, INC. VITAL SIGNS MONITOR 08/30/2013
K101539 EDAN INSTRUMENTS, INC. VITAL SIGNS MONITOR MODEL M3B 11/24/2010
K042705 ELEKON INDUSTRIES U.S.A., INC. DISPOSABLE NON-ADHESIVE SPO2 SENSORS 12/29/2004
K041522 ELEKON INDUSTRIES U.S.A., INC. FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS 09/14/2004
K041644 ELEKON INDUSTRIES U.S.A., INC. FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE) 07/29/2004
K041647 ELEKON INDUSTRIES U.S.A., INC. FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE) 09/02/2004
K042704 ELEKON INDUSTRIES U.S.A., INC. REUSABLE FINGER CLIP SPO2 SENSORS 11/26/2004
K952315 EMG SCIENTIFIC SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE 12/04/1996
K221282 Empatica S.r.l. Empatica Health Monitoring Platform 11/20/2022
K070193 ENVITEC-WISMAR GMBH ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES 05/02/2007
K043463 ENVITEC-WISMAR GMBH ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS 02/11/2005
K060675 ENVITEC-WISMAR GMBH ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS 07/17/2006
K102270 ENVITEC-WISMAR GMBH ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN 02/22/2011
K992215 ENVITEC-WISMAR GMBH MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED 03/29/2000
K133064 ENVITEC-WISMAR GMBH MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31 05/02/2014
K090438 ENVITEC-WISMAR GMBH REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR 07/24/2009
K970098 EPIC MEDICAL EQUIPMENT SERVICES, INC. E100 SERIES SPO2 SENSORS 04/30/1998
K954168 EPIC MEDICAL EQUIPMENT SERVICES, INC. E100A PULSE OXIMETER FINGER SENSOR/PROBE 09/12/1996
K990082 EPIC MEDICAL EQUIPMENT SERVICES, INC. EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09 04/09/1999
K002223 EPIC MEDICAL EQUIPMENT SERVICES, INC. EPIC SPO2 FINGER SENSOR, MODEL E412-20 08/22/2000
K964055 EPIC MEDICAL EQUIPMENT SERVICES, INC. FLEXI-SITE (E203-01)/ FLEXI-FIT (E300) 02/21/1997
K965172 EPIC MEDICAL EQUIPMENT SERVICES, INC. OXIMETER PRE-AMP CABLE 07/16/1997
K002848 EPIC MEDICAL EQUIPMENT SERVICES, INC. SPO2 WRAP SENSOR 05/24/2001
K992211 EPIC MEDICAL EQUIPMENT SERVICES, INC. SPO2 WRAP SENSOR 12/22/1999
K000831 EPIC MEDICAL EQUIPMENT SERVICES, INC. STAT-SHELL DISPOSABLE SP02 SENSOR 06/05/2000
K992092 EPIC MEDICAL EQUIPMENT SERVICES, INC. STAT-SHELL DISPOSABLE SPO2 SENSOR 12/22/1999
K013273 FUKUDA DENSHI USA, INC. FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE 12/20/2001
K052755 GE HEALTHCARE DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT 10/13/2005
K081870 GE HEALTHCARE FINLAND OY MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO 07/31/2008
K103802 GE HEALTHCARE FINLAND OY TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR 08/02/2011
K132696 GE HEALTHCARE FINLAND OY TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR 09/27/2013
K093881 GE HEALTHCARE FINLAND OY TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR 03/12/2010
K101871 GE HEALTHCARE FINLAND OY TRUSIGNAL SPO2 FINGERTIP SENSOR 10/04/2010
K022193 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N 08/01/2002
K002957 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN SOLAR SPO2 MODULE WITH MASIMO SET 10/18/2000
K082789 GENERAL MEDITECH, INC. G1B PULSE OXIMETER 01/07/2009
K112804 GUANGDONG BIOLIGHT MEDITECH CO., LTD. FINGERTIP PULSE OXIMETER 01/27/2012
K081712 GUANGDONG BIOLIGHT MEDITECH CO., LTD. FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 09/12/2008
K151287 GUANGDONG BIOLIGHT MEDITECH CO., LTD. Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D 01/06/2016
K101694 GUANGDONG BIOLIGHT MEDITECH CO., LTD. HANDHELD PULSE OXIMETER MODEL M800 09/08/2010
K201294 Guangdong Long Yao Electronic Technology Co., Ltd. Pulse Oximeter 11/27/2020
K190399 Hancock Medical, Inc. Beddr 200 System 08/05/2019
K060843 HEALTH HERO NETWORK, INC. MODIFICATION TO HEALTH BUDDY APPLIANCE 04/20/2006
K172492 Hitachi Healthcare Americas Optical Topography System ETG-4100 08/17/2018
K042501 HITACHI MEDICAL CORP. ETG-4000 OPTICAL TOPOGRAPHY SYSTEM 10/12/2004
K011320 HITACHI MEDICAL SYSTEMS AMERICA, INC. ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM 08/09/2001
K004044 HOMMED LLC. HOMMED SENTRY III PATIENT MONITOR SYSTEM 03/02/2001
K014025 HOMMED LLC. HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER 04/09/2002
K212665 Huizhou Xiaoou Technology Co., Ltd. Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) 06/22/2022
K141105 HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD. PULSE OXIMETER 12/04/2014
K171241 Hunan Accurate Bio-Medical Technology Co., Ltd. Pulse Oximeter 03/27/2018
K081572 HUNTLEIGH HEALTHCARE LTD. SMARTSIGNS MINPULSE 10/01/2008
K012706 IMAGYN MEDICAL TECHNOLOGIES, INC. IM2001 PULSE OXIMETER 03/07/2003
K984570 IN-X CORP. MINOLTA PULSOX-3/MINOLTA PULSOX-3I 08/30/2000
K120052 INTELOMED, INC CVINSIGHT 09/04/2012
K062149 INTERNATIONAL BUSINESS STRATEGIES SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES 05/31/2007
K103700 INVIVO CORPORATION ESSENTIAL MRI PATIENT MONITOR 03/15/2011
K011365 ISLAND CRITICAL CARE CORP. VITALSAT PULSE OXIMETER, MODEL IC32000 10/26/2001
K982255 IVY BIOMEDICAL SYSTEMS, INC. MODEL 2000 PULSE OXIMETER 10/22/1998
K091787 IVY BIOMEDICAL SYSTEMS, INC. MODEL 6000 TWO PARAMETER BEDSIDE MONITOR 10/09/2009
K152091 Jiangsu Konsung Bio-Medical Science & Technology Co. Ltd Fingertip Pulse Oximeter 08/18/2016
K152089 Jiangsu Konsung Bio-Medical Science & Technology Co. Ltd Wrist Pulse Oximeter 08/17/2016
K212385 Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. YUWELL Finger Pulse Oximeter 08/16/2022
K202851 JKH USA, LLC Spo2 Sensor 11/27/2020
K982331 KELLER MEDICAL SPECIALTIES PRODUCTS, INC. KELLER PULSE OXIMETER, MODEL 850+ 09/11/1998
K053419 KONICA MINOLTA SENSING, INC. KONICA MINOLTA PULSOX-300, 300I 05/11/2006
K021469 KONICA MINOLTA SENSING, INC. MINOLTA PULSOX-2 02/12/2003
K010413 KONICA MINOLTA SENSING, INC. MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI 08/02/2001
K102442 L.D. TECHNOLOGY, LLC E.S.O. (ELECTRO SENSOR OXI) 09/10/2010
K193350 Leadtek Research Inc. Leadtek Fingertip Pulse Oximeter 04/27/2020
K210032 Leadtek Research Inc. Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) 09/01/2021
K991819 MAGNA ADVANCED TECHNOLOGIES, INC. MAGNATEK 30 08/19/1999
K982907 MAGNA ADVANCED TECHNOLOGIES, INC. MAGNATEK 40 10/02/1998
K982405 MAGNA ADVANCED TECHNOLOGIES, INC. MTEK-1000 09/17/1998
K050018 MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH TESLAOXYSAT, MODEL EFOXYSATE 07/01/2005
K980299 MARQUETTE MEDICAL SYSTEMS, INC. APEX OXIMETER 04/24/1998
K033349 MASIMO CORP. AC-1 SP02 ADAPTOR CABLE, MODEL AC-1 01/28/2004
K041815 MASIMO CORP. LNCS OXIMETRY SENSORS 07/29/2004
K032551 MASIMO CORP. MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR 02/19/2004
K990966 MASIMO CORP. MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS 06/07/1999
K040259 MASIMO CORP. MASIMO SET INTELLIVUE PULSE OXIMETER MODULE 04/22/2004
K962603 MASIMO CORP. MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES 02/06/1997
K973887 MASIMO CORP. MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES 01/08/1998
K033296 MASIMO CORP. MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V 02/19/2004
K033998 MASIMO CORP. MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V 03/19/2004
K002477 MASIMO CORP. MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES 09/08/2000
K002751 MASIMO CORP. MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES 10/05/2000
K003167 MASIMO CORP. MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES 11/08/2000
K010419 MASIMO CORP. MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES 03/06/2001
K011851 MASIMO CORP. MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES 07/11/2001
K002574 MASIMO CORP. MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT 09/06/2000
K012992 MASIMO CORP. MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES 10/03/2001
K992340 MASIMO CORP. MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE 10/08/1999
K000126 MASIMO CORP. MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA 04/14/2000
K992238 MASIMO CORP. MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12) 10/08/1999
K993555 MASIMO CORP. MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES 11/19/1999
K002939 MASIMO CORP. MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER 10/06/2000
K002682 MASIMO CORP. MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES 09/13/2000
K003244 MASIMO CORP. MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES 11/08/2000
K013792 MASIMO CORP. MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES 12/11/2001
K031330 MASIMO CORP. MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES 05/12/2003
K040214 MASIMO CORP. MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES 02/25/2004
K041204 MASIMO CORP. NC SP02 ADAPTER CABLE 06/29/2004
K033298 MASIMO CORP. SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS 12/12/2003
K050252 MASIMO CORPORATION AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS 05/11/2005
K212876 Masimo Corporation Carescape SpO2 - Masimo 10/08/2021
K232389 Masimo Corporation Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue 09/07/2023
K121912 MASIMO CORPORATION E1 EAR SENSORS 07/24/2012
K060143 MASIMO CORPORATION LNCS AND SPO2.COM SENSORS 06/16/2006
K042346 MASIMO CORPORATION LNCS OXIMETRY SENSORS 09/20/2004
K083622 MASIMO CORPORATION LNCS OXIMETRY SENSORS 04/02/2009
K094046 MASIMO CORPORATION LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS 05/14/2010
K051439 MASIMO CORPORATION LNOP BLUE OXIMETRY SENSOR 07/15/2005
K050068 MASIMO CORPORATION LNOPV AD-L AND PD-L OXIMETRY SENSORS 02/09/2005
K221953 Masimo Corporation Masimo CARESCAPE SpO2 û Masimo with SpHb 08/04/2022
K101031 MASIMO CORPORATION MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 11/18/2010
K160940 Masimo Corporation Masimo Disposable Transflectance Forehead Sensor 11/23/2016
K101896 MASIMO CORPORATION MASIMO LNCS/M-LNCS OXIMETRY SENSORS 10/21/2010
K111888 MASIMO CORPORATION MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS 09/23/2011
K150314 MASIMO CORPORATION Masimo MightySat Rx Fingertip Pulse Oximeter 10/22/2015
K181956 Masimo Corporation Masimo MightySat Rx Fingertip Pulse Oximeter 01/23/2019
K182887 Masimo Corporation Masimo Rad-67 Pulse CO-Oximeter and Accessories 03/22/2019
K180046 Masimo Corporation Masimo Rad-97 and Accessories 10/23/2018
K201770 Masimo Corporation Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor 09/24/2020
K213676 Masimo Corporation Masimo Rad-G with Temperature 04/16/2023
K110028 MASIMO CORPORATION MASIMO RADICAL Y PULSE CO-OXIMETER 03/17/2011
K162675 MASIMO CORPORATION Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter 12/28/2016
K100403 MASIMO CORPORATION MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7 06/23/2010
K091057 MASIMO CORPORATION MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES 07/09/2009
K111403 MASIMO CORPORATION MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES 12/30/2011
K073024 MASIMO CORPORATION MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES 02/08/2008
K082052 MASIMO CORPORATION MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK 10/10/2008
K080238 MASIMO CORPORATION MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER 05/12/2008
K091241 MASIMO CORPORATION MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER 11/06/2009
K100428 MASIMO CORPORATION MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER 07/09/2010
K120984 MASIMO CORPORATION MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR 04/26/2013
K100617 MASIMO CORPORATION MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D 05/28/2010
K111621 MASIMO CORPORATION MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS 10/26/2011
K120657 MASIMO CORPORATION MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS 09/19/2012
K053477 MASIMO CORPORATION MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS 03/16/2006
K042536 MASIMO CORPORATION MASIMO SET RAD 57 PULSE CO-OXIMETER 01/19/2005
K092838 MASIMO CORPORATION MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 10/15/2009
K053269 MASIMO CORPORATION MASIMO SET RAD-8 PULSE OXIMETER 12/21/2005
K061204 MASIMO CORPORATION MASIMO SET RADICAL 7 PULSE CO-OXIMETER 07/27/2006
K113596 MASIMO CORPORATION MASIMO SET REUSABLE OXIMETRY SENSORS 02/24/2012
K090662 MASIMO CORPORATION MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP 08/10/2009
K121914 MASIMO CORPORATION MASIMO SET USPO2 PULSE OXIMETRY CABLE 09/07/2012
K051212 MASIMO CORPORATION MODIFICATION TO LNCS OXIMETRY SENSORS 07/12/2005
K071024 MASIMO CORPORATION MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS 06/29/2007
K081659 MASIMO CORPORATION RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L 09/09/2008
K063140 MASIMO CORPORATION RAINBOW ADHESIVE CO-OXIMETRY SENSORS 12/29/2006
K090165 MASIMO CORPORATION RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20 07/09/2009
K061191 MEASUREMENT SPECIALTIES, INC. FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2 05/22/2006
K061896 MEDIAID INC. MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N 04/12/2007
K071642 MEDIAID INC. MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER 05/02/2008
K071610 MEDIAID INC. MEDIAID PULSE OXIMETER M30 AND M34 11/05/2007
K041964 MEDIAID INC. MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS 09/14/2004
K100225 MEDIANA CO., LTD. PULSE OXIMETER MODEL P10 02/09/2011
K973970 MEDICAL CABLES, INC. SPO2 FINGER PROBES 10/06/1998
K014294 MEDICAL DATA ELECTRONICS MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 01/25/2002
K970763 MEDICAL DATA ELECTRONICS MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR 07/14/1997
K022168 MENNEN MEDICAL LTD. ENVOY 08/01/2002
K973991 METRON U.S., INC. METRON QA-510 SPO2 ANALYZER 01/16/1998
K081033 MIR MEDICAL INTL. RESEARCH SRL MIROXI 01/15/2009
K081800 MORTARA INSTRUMENT, INC. T12S TELEMETRY TRANSMITTER 09/24/2008
K070408 NELLCOR PURITAN BENNETT, INC. DURAMAX REUSABLE OXIMETRY SENSOR 05/25/2007
K991823 NELLCOR PURITAN BENNETT, INC. N-395 PULSE OXIMETER, MODEL N-395 08/25/1999
K993637 NELLCOR PURITAN BENNETT, INC. N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS 11/24/1999
K022819 NELLCOR PURITAN BENNETT, INC. NELLCOR N-200 PULSE OXIMETER, MODEL N-200 09/24/2002
K060576 NELLCOR PURITAN BENNETT, INC. NELLCOR OXIMAX N-600X PULSE OXIMETER 08/14/2006
K052186 NELLCOR PURITAN BENNETT, INC. NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P 11/10/2005
K963707 NELLCOR PURITAN BENNETT, INC. NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) 12/13/1996
K982728 NELLCOR PURITAN BENNETT, INC. NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C 12/07/1998
K971946 NELLCOR PURITAN BENNETT, INC. NPB-190 PULSE OXIMETER (NPB-190) 08/25/1997
K972468 NELLCOR PURITAN BENNETT, INC. NPB-195 PULSE OXIMETER 09/25/1997
K972837 NELLCOR PURITAN BENNETT, INC. NPB-290 PULSE OXIMETER (NPB-290) 10/21/1997
K973147 NELLCOR PURITAN BENNETT, INC. NPB-295 PULSE OXIMETER 11/14/1997
K021089 NELLCOR PURITAN BENNETT, INC. OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR 06/19/2002
K021090 NELLCOR PURITAN BENNETT, INC. OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER 05/08/2002
K051271 NELLCOR PURITAN BENNETT, INC. OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR 01/10/2006
K051352 NELLCOR PURITAN BENNETT, INC. OXIMAX NPB-40 HANDHELD PULSE OXIMETER 08/11/2005
K012891 NELLCOR PURITAN BENNETT, INC. OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) 03/07/2002
K030930 NELLCOR PURITAN BENNETT, INC. OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N 05/23/2003
K961450 NELLCOR PURITAN BENNETT, INC. SCORE SOFTWARE 08/01/1996
K123797 NEW TECH, INC. NT1D VITAL SIGNS MONITOR 08/27/2013
K992455 NIHON KOHDEN AMERICA, INC. NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES 01/07/2000
K974292 NIHON KOHDEN AMERICA, INC. NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES 06/08/1998
K172625 Nonin Medical Inc. Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor 05/11/2018
K043359 NONIN MEDICAL, INC. 4100 PATIENT OXIMETER MODULE 01/07/2005
K945290 NONIN MEDICAL, INC. 8500A PULSE OXIMETER 02/11/1997
K052669 NONIN MEDICAL, INC. AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100 12/23/2005
K041156 NONIN MEDICAL, INC. AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 06/09/2004
K071285 NONIN MEDICAL, INC. DIGITAL PULSE OXIMETER, MODEL 7500 07/12/2007
K071415 NONIN MEDICAL, INC. DIGITAL PULSE OXIMETER, MODEL 7500FO 08/08/2007
K092678 NONIN MEDICAL, INC. EVISION DATA MANAGEMENT SOFTWARE 10/01/2009
K081285 NONIN MEDICAL, INC. FINGER PULSE OXIMETER, MODEL 9560 06/05/2008
K192900 Nonin Medical, Inc. H500 Multi-Sensing Oximetry System 06/29/2020
K063752 NONIN MEDICAL, INC. LIFESENSE, MODEL LS1-9R 05/04/2007
K002690 NONIN MEDICAL, INC. MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 10/11/2000
K050056 NONIN MEDICAL, INC. MODEL 2500A PALMSAT PULSE OXIMETER 06/21/2005
K030668 NONIN MEDICAL, INC. MODEL 3100 WRISTOX PULSE OXIMETER 10/17/2003
K160865 NONIN MEDICAL, INC. Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C S 08/05/2016
K001930 NONIN MEDICAL, INC. MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 07/20/2000
K023044 NONIN MEDICAL, INC. MODEL 9600, AVANT PULSE OXIMETER 07/23/2003
K160231 NONIN MEDICAL, INC. Model X-100C CO-MetÖ Oximetry System 12/23/2016
K040589 NONIN MEDICAL, INC. MODIFICATION TO AVANT 9600 PULSE OXIMETER 06/03/2004
K001085 NONIN MEDICAL, INC. MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500 05/01/2000
K080255 NONIN MEDICAL, INC. NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER 05/23/2008
K013319 NONIN MEDICAL, INC. NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR 01/03/2002
K033307 NONIN MEDICAL, INC. NVISION DATA MANAGEMENT SOFTWARE 05/06/2004
K051107 NONIN MEDICAL, INC. ONYX II FINGER PULSE OXIMETER, MODEL 9550 06/01/2005
K053130 NONIN MEDICAL, INC. ONYX II FINGER PULSE OXIMETER, MODEL 9550 01/11/2006
K140785 NONIN MEDICAL, INC. PULSE OXIMETER 07/07/2014
K102350 NONIN MEDICAL, INC. PULSE OXIMETER 12/22/2010
K112843 NONIN MEDICAL, INC. PULSE OXIMETER 04/19/2012
K131021 NONIN MEDICAL, INC. PULSE OXIMETER 09/11/2013
K191403 Nonin Medical, Inc. Pulse Oximeter 12/20/2019
K092101 NONIN MEDICAL, INC. REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES 10/21/2009
K132402 NONIN MEDICAL, INC. SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM 02/21/2014
K093306 NONIN MEDICAL, INC. SINGLE-PATIENT USE DISPOSABLE SENSOR 03/04/2010
K093853 NONIN MEDICAL, INC. SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES 06/04/2010
K052829 NONIN MEDICAL, INC. WRISTOX MODEL 3100 PULSE OXIMETER 11/10/2005
K993979 NOVAMETRIX MEDICAL SYSTEMS, INC. MARSPO2, MODEL 2001 02/22/2000
K000794 NOVAMETRIX MEDICAL SYSTEMS, INC. MODIFICATION TO MARSPO2, MODEL 2001 04/10/2000
K010451 NOVAMETRIX MEDICAL SYSTEMS, INC. NOVAMETRIX MARQUETTE COMPATIBLE SENSORS 04/25/2001
K962127 OHMEDA MEDICAL OHMEDA 3800 PULSE OXIMETER 10/10/1996
K181270 Orantech Inc. Disposable SpO2 Sensors, Reusable SpO2 Sensors 09/07/2018
K072295 ORIDION CAPNOGRAPHY, INC. CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE 10/11/2007
K101995 ORIDION CAPNOGRAPHY, INC. CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD 01/11/2011
K060065 ORIDION CAPNOGRAPHY, INC. CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR 05/04/2006
K082268 ORIDION CAPNOGRAPHY, INC. CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX 02/06/2009
K024300 ORIDION MEDICAL 1987 LTD. MICROCAP PLUS/NPB-75 04/03/2003
K124041 ORSENSE LTD NBM-200MP 10/17/2013
K091564 ORSENSE LTD NBM-200MP PULSE OXIMETRY DEVICE 03/19/2010
K142209 ORSENSE LTD Pulse oximeter NBM-200 01/16/2015
K012533 OSI MEDICAL, INC. MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES 08/22/2001
K012626 OSI MEDICAL, INC. OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR 11/02/2001
K002036 OSI MEDICAL, INC. OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD 04/17/2001
K222597 Owlet Baby Care, Inc. BabySat 3 06/16/2023
K163382 Oxitone Medical Ltd. Oxitone 1000 05/09/2017
K100815 OXYPULSE OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 06/16/2010
K994372 PALCO LABS, INC. MODEL 120 04/28/2000
K002787 PALCO LABS, INC. MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 11/29/2000
K060616 PHD MEDICAL NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100 06/29/2006
K062338 PHD MEDICAL TELEVISIT 10/25/2006
K062455 PHILIPS MEDICAL SYSTEMS PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL 11/03/2006
K021778 PHILIPS MEDICAL SYSTEMS PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B 07/17/2002
K062605 PHILIPS MEDICAL SYSTEMS PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T 11/09/2006
K030973 PHILIPS MEDICAL SYSTEMS PICOSAT II SPO2 PULSE OXIMETRY MODULE 07/23/2003
K041674 PHILIPS MEDICAL SYSTEMS THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT 07/19/2004
K062268 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03 10/18/2006
K063783 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A 04/27/2007
K032979 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T 02/20/2004
K033715 PHILIPS MEDICAL SYSTEMS, INC. PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER 02/13/2004
K090360 PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH PHILIPS M3001A MULTI MEASUREMENT SERVER 05/04/2009
K052377 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. 11/17/2005
K042306 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A 10/15/2004
K081937 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE 08/29/2008
K091572 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN DISPOSABLE SPO2 SENSOR M1134A 09/22/2009
K101600 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL 08/31/2010
K001995 QRS DIAGNOSTIC, LLC. SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER 09/08/2000
K083079 QUANTA COMPUTER INC. QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100 03/05/2009
K964978 QUINTON, INC. VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) 05/21/1997
K063434 RADIOMETER BASEL AG TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM 01/22/2007
K001708 RESPIRONICS GEORGIA, INC. PROFOX SOFTWARE, MODEL 920M-41 03/01/2001
K032755 RESPIRONICS NOVAMETRIX, INC. MODEL 509M PULSE OXIMETER, MODEL 509M 05/21/2004
K032949 RESPIRONICS NOVAMETRIX, INC. SPOT CHECK PULSE OXIMETER,512/513 08/23/2004
K032971 RESPIRONICS NOVAMETRIX, INC. TIDAL WAVE SP MODEL 710/715 AND 715 08/26/2004
K972829 RESPIRONICS, INC. CRICKET 2000 RECORDING PULSE OXIMETER 10/28/1997
K191574 S.L.P. Ltd. OxSAT 100 04/09/2020
K040178 S.P.O. MEDICAL EQUIPMENT, LTD. PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE 09/10/2004
K011974 SENSIDYNE, INC. SENSAID 02/12/2002
K021246 SENSIDYNE, INC. SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3 05/13/2002
K071672 SENTEC AG SENTEC DIGITAL MONITORING SYSTEM 09/12/2007
K142687 Shanghai Berry Electronic Tech Co., Ltd Pulse Oximeter 04/13/2015
K172141 Shanghai Berry Electronic Tech Co., Ltd Pulse Oximeter 04/04/2018
K113865 SHARP CORPORATION PULTOL 03/21/2012
K200414 Shenzhen Aeon Technology Co., Ltd. Pulse Oximeter 09/23/2020
K190869 Shenzhen Aeon Technology Co., Ltd. Pulse Oximeter 09/13/2019
K202173 Shenzhen AOJ Medical Technology Co., Ltd. Pulse Oximeter 12/07/2020
K211143 Shenzhen brav electronic technologies co., Ltd Pulse Oximeter 07/17/2023
K202324 Shenzhen BSX Technology Electronics Co., Ltd. Fingertip Pulse Oximeter 12/14/2020
K153184 SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. Caremed Reusable & Disposable SPO2 Sensors 01/04/2017
K191279 Shenzhen Caremed Medical Technology Co., Ltd. Disposable SpO2 Sensor 12/06/2019
K200069 Shenzhen Changke Connect Electronics Co., Ltd. Disposable SpO2 Sensor 03/13/2020
K191420 Shenzhen Changke Connect Electronics Co., Ltd. Reusable SpO2 Sensor 10/11/2019
K221798 Shenzhen Changkun Technology Co., Ltd. Finger Pulse Oximeter, Model: X1906P 05/04/2023
K173368 Shenzhen Coreray Technology, Ltd. Reusable & Disposable SpO2 Sensors 08/31/2018
K063641 SHENZHEN CREATIVE INDUSTRY CO., LTD PC-60, NON-INVASIVEPULSE OXIMETER 07/13/2007
K120502 SHENZHEN CREATIVE INDUSTRY CO., LTD PC-60NW FINGERTIP OXIMETER 12/07/2012
K093016 SHENZHEN CREATIVE INDUSTRY CO., LTD VITAL SIGNS MONITOR 03/30/2010
K172792 Shenzhen Creative Industry Co., Ltd. Handheld Pulse Oximeter, Model SP-20 11/13/2018
K192343 Shenzhen Creative Industry Co., Ltd. Patient Monitor 12/31/2019
K201468 Shenzhen Creative Industry Co., Ltd. Pulse Oximeter 01/25/2021
K150093 SHENZHEN CREATIVE INDUSTRY CO., LTD. Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 06/03/2015
K103584 SHENZHEN ENVISEN INDUSTRY CO. LIMITED ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS 06/10/2011
K163135 SHENZHEN FITFAITH TECHNOLOGY CO.,LTD Finger Pulse Oximeter 09/19/2017
K173045 Shenzhen Greatmade Tech limited Oximeter 06/05/2018
K203854 Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd. Pulse Oximeter 04/23/2021
K173123 Shenzhen IMDK Medical Technology Co., Ltd. Pulse Oximeter 08/13/2018
K221979 Shenzhen IMDK Medical Technology CO., Ltd. Pulse Oximeter (Model C101A2, C101B1, C101A3) 10/16/2022
K140582 SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD FINGERTIP PULSE OXIMETER 08/28/2014
K170965 Shenzhen Jumper Medical Equipment Co., Ltd. Fingertip Pulse Oximeter 11/03/2017
K123801 SHENZHEN KINGYIELD TECHNOLOGY CO., LTD FINGER PULSE OXIMETER 05/28/2013
K202776 Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. Fingertip pulse oximeter 03/01/2021
K202743 Shenzhen Med-link Electronics Tech Co., Ltd Med-Link Temp-pulse Oximeter 03/01/2021
K212752 Shenzhen Med-link Electronics Tech Co., Ltd. Med-link Pulse Oximeter 05/20/2022
K113727 SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. SHENZHEN MED-LINK PULSE OXIMETER PROBE 03/21/2013
K083010 SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR 06/10/2009
K152390 Shenzhen Medke Technology Co., LTD Medke Oximetry Finger Sensor 08/18/2016
K212300 Shenzhen Mericonn Technology Co., Ltd. Pulse Oximeter 02/25/2022
K052693 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD PM-50 PULSE OXIMETER 03/30/2006
K072235 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR 10/19/2007
K072581 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD PM-60 PULSE OXIMETER 01/08/2008
K061442 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD PULSE OXIMETER, MODEL PM-50 09/05/2006
K211632 Shenzhen Narig Bio-Medical Technology Co., Ltd. Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) 01/14/2022
K201384 Shenzhen Raysintone Technology CO., Ltd Pulse Oximeter 12/07/2020
K192608 Shenzhen SINO-K Medical Technology Co., Ltd. Disposable SpO2 Sensor 01/24/2020
K183277 Shenzhen Upnmed Equipment Co., Ltd. SpO2 Sensor 05/15/2019
K191088 Shenzhen Viatom Technology Co., Ltd. Checkme O2 Pulse Oximeter 12/02/2019
K203812 Shenzhen Viatom Technology Co., Ltd. Oxyfit Pulse Oximeter 11/08/2022
K213430 Shenzhen Witleaf Medical Electronics Co.,Ltd Fingertip Pulse Oximeter 12/30/2022
K213431 Shenzhen Witleaf Medical Electronics Co.,Ltd Handheld Pulse Oximeter 02/26/2023
K191430 Shenzhen Yimi Life-Technology Co.,Ltd. Pulse Oximeter 10/18/2019
K213984 ShenZhen ZhengKang Technology Co., Ltd. Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) 12/16/2022
K051736 SHUNSUKE NAKANISHI FOX PULSE OXIMETER 12/02/2005
K012770 SIEMENS MEDICAL SOLUTIONS USA, INC. INFINITY MICRO2+ 07/23/2002
K973222 SIEMENS MEDICAL SOLUTIONS USA, INC. SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER 09/04/1997
K970368 SIEMENS MEDICAL SOLUTIONS USA, INC. SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER 05/06/1997
K991661 SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER 05/28/1999
K022766 SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER 09/05/2002
K030640 SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS MICRO2+ WITH VAI SOFTWARE 06/03/2003
K070732 SMITHS MEDICAL PM, INC. BCI AUTOCON 3304 DIGITAL PULSE OXIMETER 07/09/2007
K083787 SMITHS MEDICAL PM, INC. BCI WW1000 PULSE OXIMETER, MODEL WW1000 04/15/2009
K083705 SMITHS MEDICAL PM, INC. BCI WW1020 PULSE OXIMETER, MODEL WW1020 04/09/2009
K090205 SMITHS MEDICAL PM, INC. BCI WW1021 PC APPLICATION 04/28/2009
K083557 SMITHS MEDICAL PM, INC. BCI WW1030 PULSE OXIMETER 05/01/2009
K100077 SOLARIS MEDICAL TECHNOLOGY, INC. NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 10/07/2010
K061931 SOLARIS MEDICAL TECHNOLOGY, INC. SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101 01/31/2007
K092950 SOLARIS MEDICAL TECHNOLOGY, INC. SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES 03/12/2010
K073249 SOLARIS MEDICAL TECHNOLOGY, INC. SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES 07/25/2008
K001842 SOMANETICS CORP. ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100 09/15/2000
K960614 SOMANETICS CORP. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 06/05/1996
K971628 SOMANETICS CORP. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 10/10/1997
K981655 SPACELABS MEDICAL, INC. SPACELABS MEDICAL DISPOSABLE SP02 SENSOR 12/03/1999
K181352 Spry Health, Inc. Loop System 03/29/2019
K211140 Stryker Sustainability Solutions Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Re 03/08/2022
K201887 SurePulse Medical Limited VS Newborn Heart Rate Monitor 07/23/2021
K181738 Surgical Instrument Service and Savings Inc (dba Medline Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors 03/22/2019
K052619 T F & G PRODUCTS THE FINGER GUARD 01/06/2006
K151024 TAIDOC TECHNOLOGY CORPORATION Finger Type Pulse Oximeter 03/02/2016
K101012 TaiDoc Technology Corporation V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201 12/15/2010
K110893 TaiDoc Technology Corporation VTRUST FINGER TYPE PULSE OXIMETER 11/22/2011
K162580 TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC. Guardian Angel GA1000 Digital Vital Sign Monitoring System 03/03/2017
K182822 Taiwan Aulisa Medical Devices Technologies, Inc. Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System 03/01/2019
K183067 Taiwan Aulisa Medical Devices Technologies, Inc. Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System 03/01/2019
K203208 Taiwan Aulisa Medical Devices Technologies, Inc. Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System 06/12/2022
K191207 Taiwan Aulisa Medical Devices Technologies, Inc. Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System 06/25/2019
K183556 Taiwan Biophotonic Corporation oCare Wrist Pulse Oximeter 02/15/2019
K053420 TENACORE HOLDINGS, INC. TENACORE SP02 SENSORS 11/15/2006
K200537 True Wearables, Inc. Oxxiom 07/03/2020
K082546 UNIMED MEDICAL SUPPLIES INC. REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91) 12/02/2008
K142832 UNIMED MEDICAL SUPPLIES INC. Unimed Disposable and Reusable SPO2 Sensors 02/06/2015
K222213 Unimed Medical Supplies, Inc. Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) 12/19/2022
K964821 VENTREX, INC. COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 07/16/1997
K092324 VIASYS HEALTHCARE GMBH SPIROPRO 09/03/2009
K031515 VIASYS HEALTHCARE GMBH SPIROPRO SPO2 11/14/2003
K040581 VITEL NET MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM 05/27/2004
K031740 WELCH ALLYN PROTOCOL, INC. VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES 08/26/2003
K022084 WELCH ALLYN, INC. ATLAS MONITOR, MODELS 200,210,220 09/26/2002
K053381 WELCH ALLYN, INC. WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE 06/15/2006
K022163 WELCH ALLYN, INC. WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 09/17/2002
K213515 Wesper Inc. WesperO2 06/10/2022
K122996 XHALE ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085 04/10/2013
K171423 Xhale, Inc Nasal Alar SpO2 Sensor 07/27/2017
K143216 Xhale, Inc. Assurance Alar / Nasal SpO2 Sensor 03/17/2015
K180685 Xiamen Acurio Instruments Co., Ltd AS-3XX Series Fingertip Pulse Oximeter 11/29/2018
K201360 Xinkang Medical Instrument Co. Ltd. Reusable and Disposable SpO2 Sensors 08/19/2020
K161938 XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD Fingertip Pulse Oximeter 05/08/2017
K210274 Zhuhai Linte Medical Instrument Co., Ltd. Fingertip Pulse Oximeter 07/30/2021


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact