FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K082887 |
ADVANCED INSTRUMENTATIONS, INC. |
PM-1000F+PATIENT MONITOR |
01/16/2009 |
K002009 |
AGILENT TECHNOLOGIES, INC. |
HP M2376A DEVICE LINK SYSTEM, MODEL M2376A |
08/02/2000 |
K003107 |
AGILENT TECHNOLOGIES, INC. |
M2376A DEVICELINK SYSTEM |
10/19/2000 |
K010048 |
AGILENT TECHNOLOGIES, INC. |
M2376A DEVICELINK SYSTEM |
02/01/2001 |
K010453 |
AGILENT TECHNOLOGIES, INC. |
M2376A DEVICELINK SYSTEM |
03/02/2001 |
K002967 |
AGILENT TECHNOLOGIES, INC. |
M2376A DEVICELINK SYSTEM, MODEL M2376A |
10/18/2000 |
K003622 |
AGILENT TECHNOLOGIES, INC. |
M2376A DEVICELINK SYSTEM, MODEL M2376A |
12/18/2000 |
K010342 |
AGILENT TECHNOLOGIES, INC. |
M2376A DEVICELINK SYSTEM, MODEL M2376A |
02/14/2001 |
K011578 |
AGILENT TECHNOLOGIES, INC. |
M2376A DEVICELINK SYSTEM, MODEL M2376A |
06/08/2001 |
K012094 |
AGILENT TECHNOLOGIES, INC. |
MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A |
07/20/2001 |
K000635 |
AGILENT TECHNOLOGIES, INC. |
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM |
03/20/2000 |
K001776 |
AGILENT TECHNOLOGIES, INC. |
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A |
06/30/2000 |
K182226 |
AirStrip Technologies, Inc. |
AirStrip RPM InvisionHeart Adapter |
09/11/2018 |
K133394 |
AIRSTRIP TECHNOLOGIES, LP |
AIRSTRIP REMOTE PATIENT MONITORING |
02/06/2014 |
K133450 |
AIRSTRIP TECHNOLOGIES, LP |
AIRSTRIP REMOTE PATIENT MONITORING |
02/14/2014 |
K110503 |
AIRSTRIP TECHNOLOGIES, LP |
AIRSTRIP REMOTE PATIENT MONITORING (RPM) |
03/10/2011 |
K112235 |
AIRSTRIP TECHNOLOGIES, LP |
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING |
08/26/2011 |
K121871 |
AIRSTRIP TECHNOLOGIES, LP |
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING |
07/03/2012 |
K122133 |
AIRSTRIP TECHNOLOGIES, LP |
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING |
10/02/2012 |
K100133 |
AIRSTRIP TECHNOLOGIES, LP |
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1 |
07/23/2010 |
K131786 |
AIRSTRIP TECHNOLOGIES, LP |
AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER |
07/03/2013 |
K153335 |
ALERTWATCH LLC |
AlertWatch: OR |
03/15/2016 |
K980688 |
ALLIANCE INSTRUMENTS |
INTEGRITI PATIENT MONITOR |
03/16/1999 |
K143372 |
AMBIENT CLINICAL ANALYTICS |
AWARE |
04/02/2015 |
K151839 |
AMC Health |
AMC Health VitalCaregiving System |
09/09/2016 |
K003999 |
AMERICAN TELECARE, INC. |
AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010 |
06/28/2001 |
K182401 |
AmZetta Technologies Private Limited |
B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter |
08/28/2019 |
K041376 |
ANALOGIC CORP. |
C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A |
07/20/2004 |
K181541 |
Andon health Co., Ltd |
Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK |
04/16/2019 |
K113165 |
ATHENA GTX |
MINI-MEDIC |
02/02/2012 |
K191989 |
Athena GTX |
WVSM (Wireless Vital Signs Monitor) RWC + miniCap |
01/29/2020 |
K101674 |
ATHENA GTX |
WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 |
07/21/2010 |
K130957 |
ATHENA GTX |
WVSM (WIRLESS VITAL SIGNS MONITOR) |
04/30/2013 |
K153079 |
AXEO MEDICAL TECHNOLOGIES, LLC |
Axeo 3 Patient Monitor |
03/17/2016 |
K010770 |
BCI, INC. |
BCI ADVISOR VITAL SIGNS MONITOR (9200) |
06/12/2001 |
K124038 |
BEDSIDE CLINICAL SYSTEMS INC |
BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS) |
06/21/2013 |
K211754 |
Beijing Choice Electronic Technology Co., Ltd. |
Vital Signs Monitor |
11/15/2021 |
K100740 |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
MD2000B VITAL SIGN MONITOR, MODEL MD2000B |
07/09/2010 |
K082787 |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
VITAL SIGNS MONITOR, MODEL: MD500B |
01/12/2009 |
K171361 |
Bettercare S.L. |
BETTERCARE PLATFORM - ADVANCED WEB CLIENT |
02/05/2018 |
K102579 |
BIOLOGICAL SIGNAL PROCESSING LTD. |
HYPERQ AD-100 SYSTEM |
12/02/2010 |
K042981 |
BIOLOGICAL SIGNAL PROCESSING LTD. |
HYPERQ SYSTEM |
03/10/2005 |
K070624 |
BIOLOGICAL SIGNAL PROCESSING LTD. |
HYPERQ SYSTEM |
04/06/2007 |
K082564 |
BIOLOGICAL SIGNAL PROCESSING, LTD. |
HYPERQ SYSTEM |
10/20/2008 |
K072389 |
BIOLOGICAL SIGNAL PROCESSING, LTD. |
MODIFICATION TO HYPERQ SYSTEM |
09/18/2007 |
K082008 |
BIONET CO., LTD. |
BIONET BM3PLUS PATIENT MONITOR |
12/11/2008 |
K060756 |
BMC GESELLSCHAFT FUR MEDIZINTECHNIK MBH |
MEDLOG, MODEL 1-0-10 |
10/30/2006 |
K213335 |
Capsule Surveillance Technologies, SAS /Capsule Tech, Inc. |
Capsule Surveillance System |
01/14/2022 |
K113835 |
CAPSULE TECH INC. |
DATACAPTOR SYSTEM |
06/27/2012 |
K013019 |
CAPSULE TECHNOLOGIE |
DATACAPTOR |
12/18/2001 |
K032142 |
CAPSULE TECHNOLOGIE |
DATACAPTOR |
08/08/2003 |
K020197 |
CAPSULE TECHNOLOGIE |
MODIFICATION TO DATACAPTOR |
02/21/2002 |
K180734 |
Capsule Technologie |
SmartLinx Vitals Plus Patient Monitoring System |
08/08/2018 |
K183638 |
Capsule Technologie |
SmartLinx Vitals Plus Patient Monitoring System |
04/17/2019 |
K210204 |
Capsule Technologie SAS |
Capsule Vitals Plus Patient Monitoring System |
10/19/2021 |
K200856 |
Capsule Technologie SAS |
SmartLinx Vitals Plus Patient Monitoring System |
07/10/2020 |
K151071 |
CAPSULE TECHNOLOGIE SAS |
SmartLinx Vitals Plus Patient Monitoring System |
09/17/2015 |
K171751 |
Capsule Technologie, SAS |
SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module |
10/24/2017 |
K130411 |
CAS MEDICAL SYSTEMS, INC. |
740 SELECT |
05/29/2013 |
K140430 |
CAS MEDICAL SYSTEMS, INC. |
740 SELECT |
06/13/2014 |
K150620 |
CAS MEDICAL SYSTEMS, INC. |
740 SELECT |
05/08/2015 |
K051896 |
CAS MEDICAL SYSTEMS, INC. |
MODEL 750E SERIES MONITOR |
12/16/2005 |
K063087 |
CAS MEDICAL SYSTEMS, INC. |
MODIFICATION TO MODEL 750 SERIES MONITOR |
12/11/2006 |
K222330 |
Casana Care, Inc. |
The Heart Seat |
04/24/2023 |
K230881 |
Change Healthcare Israel Ltd. |
Change Healthcare Cardiology HemodynamicsÖ |
09/11/2023 |
K022537 |
COLIN MEDICAL INSTRUMENTS CORP. |
PRESS-MATE PM-2100 VITAL SIGN MONITOR |
09/13/2002 |
K101127 |
CONTEC MEDICAL SYSTEM CO., LTD. |
PATIENT MONITOR, MODEL PM50 |
06/11/2010 |
K130796 |
COVIDIEN |
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM |
05/09/2013 |
K132604 |
COVIDIEN |
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM |
12/04/2013 |
K140339 |
COVIDIEN |
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM |
04/10/2014 |
K160718 |
COVIDIEN |
Vital Sync Informatics Manager & Virtual Patient Monitoring Platform |
11/14/2016 |
K123002 |
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. |
VITAL SYNC SYSTEM |
02/27/2013 |
K001020 |
CRITICARE SYSTEMS, INC. |
8100 VITAL SIGNS MONITOR |
04/28/2000 |
K012059 |
CRITICARE SYSTEMS, INC. |
8100/8500 VITAL SIGNS MONITOR |
08/01/2001 |
K042569 |
CRITICARE SYSTEMS, INC. |
8600 VITAL SIGNS MONITOR |
09/29/2004 |
K992638 |
CRITIKON COMPANY,LLC |
DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 |
02/24/2000 |
K100424 |
DANMEDICAL LIMITED |
DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS |
03/21/2011 |
K041907 |
DATASCOPE CORP. |
TRIO MONITOR |
07/23/2004 |
K051897 |
DATASCOPE CORP. |
TRIO MONITOR |
08/12/2005 |
K032338 |
DATASCOPE CORP. |
TRIO MONITOR MODEL 0998-00-0600 |
02/11/2004 |
K142106 |
DECISIO HEALTH, INC. |
DECISIO HEALTH PATIENT DASHBOARD |
01/18/2015 |
K152645 |
DICTUM HEALTH, INC |
Dictum Health |
02/09/2016 |
K170798 |
Dictum Health, Inc. |
Dictum Health |
07/14/2017 |
K183687 |
Digicare Biomedical Technology, Inc. |
LifeWindow LW8 Lite |
09/25/2019 |
K190090 |
DynoSense Corp. |
DynoSense Vital Sign Measuring System |
08/02/2019 |
K983928 |
EASTMAN KODAK COMPANY |
KODAK HOME HEALTH MONITORING SYSTEM |
02/11/2000 |
K202892 |
Edan Instruments, Inc. |
Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s |
01/28/2021 |
K192004 |
Eko Devices Inc |
Eko Analysis Software |
01/15/2020 |
K190273 |
Etiometry, Inc. |
T3 Platform software |
12/08/2019 |
K202306 |
Etiometry, Inc. |
T3 Platform software |
11/25/2020 |
K142732 |
Etiometry, Inc. |
T3 Software |
03/04/2015 |
K151715 |
Etiometry, Inc. |
T3 Software |
10/29/2015 |
K163065 |
ETIOMETRY, INC. |
T3 Software |
05/26/2017 |
K171056 |
Excel Medical Electronics, LLC |
WAVE Clinical Platform |
01/04/2018 |
K170032 |
Fysicon BV |
QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP |
09/08/2017 |
K142840 |
GE HEALTHCARE |
Unity Network ID |
01/07/2015 |
K170199 |
GE Healthcare |
Unity Network ID |
05/12/2017 |
K183116 |
GE Healthcare |
Unity Network ID |
12/06/2018 |
K102426 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
CARESCAPE MODEL V100 VITAL SIGNS MONITOR |
10/20/2010 |
K020022 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410 |
02/01/2002 |
K021435 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N |
05/22/2002 |
K014255 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400 |
07/02/2002 |
K033672 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MODIFICATION TO UNITY NETWORK ID |
12/18/2003 |
K040559 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MODIFICATION TO UNITY NETWORK ID |
06/04/2004 |
K071982 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MODIFICATION TO: UNITY NETWORK ID |
09/21/2007 |
K051518 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
UNITY NETWORK ID |
07/08/2005 |
K103432 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC |
UNITY NETWORK ID |
12/17/2010 |
K230626 |
GE Medical Systems Information Technologies, Inc. |
PortraitÖ Central Viewer Application (Portrait CV A01), Portrait Ö Core Services (Portrait CSS01), PortraitÖ Clinical Alarming Unit (Portrait CAU01); PortraitÖ Mobile Patient Monitor (Portrait HUB01), PortraitÖ Sensor Battery (Portrait SBT01), PortraitÖ B |
08/11/2023 |
K021454 |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
UNITY NETWORK ID |
10/01/2002 |
K112877 |
GOLDWAY (US), INC. |
COMEN MULTI-PARAMETER PATIENT MONITOR |
11/07/2012 |
K033988 |
GOLDWAY (US), INC. |
GOLDWAY UT4000A VITAL SIGNS MONITOR |
02/25/2004 |
K021154 |
GOLDWAY US, INC. |
GOLDWAY PATIENT MONITOR, MODEL # UT4000F |
04/11/2003 |
K120193 |
GUANGDONG BIOLIGHT MEDITECH CO., LTD |
ANY VIEW PATIENT MONITORS |
06/29/2012 |
K113833 |
GUANGDONG BIOLIGHT MEDITECH CO., LTD |
VITAL SIGNS MONITOR |
05/01/2012 |
K131898 |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
A SERIES AND Q SERIES PATIENT MONITORS |
02/18/2014 |
K131762 |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
HANDHELD MONITOR |
06/06/2014 |
K181919 |
Guangdong Biolight Meditech Co., Ltd. |
Patient Monitor |
04/05/2019 |
K162234 |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
Truscope Ultra Patient Monitor |
01/04/2017 |
K153135 |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
VITAL SIGNS MONITOR |
02/25/2016 |
K033133 |
HEALTHCARE VISION, INC. |
TELECARE D.R. SERVER SOFTWARE SYSTEM |
04/13/2004 |
K033283 |
ICU DATASYSTEMS, INC. |
CENTRA VIEW DEVICE LINK SYSTEM |
10/27/2003 |
K012349 |
IMDSOFT, LTD. |
METAVISION CLINICAL INFORMATION SYSTEM |
01/29/2002 |
K142244 |
INFINIUM MEDICAL |
CLEO PATIENT MONITOR |
02/06/2015 |
K103268 |
INFINIUM MEDICAL |
OMNI EXPRESS |
11/23/2010 |
K103737 |
INFINIUM MEDICAL |
OMNI II PATIENT MONITOR |
06/02/2011 |
K101052 |
INFINIUM MEDICAL |
OMNI III PATIENT MONITOR |
08/11/2010 |
K132229 |
INFINIUM MEDICAL |
OMNI PATENT MONITORS |
02/21/2014 |
K112329 |
INFINIUM MEDICAL |
OMNI PATIENT MONITOR |
09/08/2011 |
K133810 |
INNOKAS YHTYMA |
VC150 VITAL SIGNS MONITOR |
10/30/2014 |
K082256 |
INTEGRATED MEDICAL SYSTEMS, INC. |
LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE |
09/26/2008 |
K090785 |
INVIVO CORP. |
MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 |
12/15/2009 |
K053462 |
INVIVO CORPORATION |
3160 MRI PATIENT MONITORING SYSTEM |
01/18/2006 |
K121424 |
INVIVO CORPORATION |
EXPRESSION INFORMATION PORTAL |
06/13/2012 |
K131382 |
INVIVO CORPORATION |
EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL |
07/15/2013 |
K152330 |
INVIVO CORPORATION |
Expression MR400 MRI Patient Monitoring System |
12/23/2015 |
K132359 |
INVIVO CORPORATION |
MRI PATIENT MONITORING SYSTEM |
08/30/2013 |
K124061 |
INVIVO CORPORATION |
MRI PATIENT MONITORING SYSTEM (MODEL 865214) |
02/22/2013 |
K212227 |
Invivo Corporation |
Philips MR Patient Care Portal |
09/30/2021 |
K041918 |
INVIVO RESEARCH, INC. |
INTEGRATED PATIENT MONITORING SYSTEM |
10/15/2004 |
K040915 |
INVIVO RESEARCH, INC. |
MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M |
09/22/2004 |
K050399 |
INVIVO RESEARCH, INC. |
MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 |
08/26/2005 |
K002030 |
INVIVO RESEARCH, INC. |
OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES |
09/26/2000 |
K172200 |
Iradimed Corporation |
3880 MRI Patient Monitoring System |
10/25/2017 |
K182900 |
Iradimed Corporation |
3880 MRI Patient Monitoring System |
12/14/2018 |
K180903 |
Iradimed Corporation |
3880 MRI Patient Monitoring System |
03/29/2019 |
K083229 |
L.D. TECHNOLOGY, LLC |
E.S TECK ( ELECTRO SENSOR TECK) |
02/23/2009 |
K061816 |
LARSEN & TOUBRO LIMITED |
GALAXY |
07/12/2006 |
K082685 |
LARSEN & TOUBRO LIMITED |
GALAXY 55 |
09/26/2008 |
K043370 |
LARSEN & TOUBRO LIMITED |
PLANET 50 MONITORING SYSTEM |
02/15/2005 |
K071472 |
LARSEN & TOUBRO LIMITED |
PLANET 55 |
09/21/2007 |
K032871 |
LARSEN & TOUBRO LIMITED |
PLANET MONITORING SYSTEM |
11/10/2003 |
K081552 |
LARSEN & TOUBRO LIMITED |
SKYLINE 55 |
07/31/2008 |
K092153 |
LARSEN & TOUBRO LIMITED |
SKYLINE 55, MODEL VER 1 |
11/20/2009 |
K032867 |
LARSEN & TOUBRO LIMITED |
STAR (LUNAR SERIES) MONITORING SYSTEM |
11/10/2003 |
K051608 |
LARSEN & TOUBRO LIMITED |
STAR 50 MONITORING SYSTEM |
06/29/2005 |
K103686 |
LARSEN & TOUBRO LIMITED |
STAR 50 N |
03/15/2011 |
K080173 |
LARSEN & TOUBRO LIMITED |
STAR 55 |
02/08/2008 |
K093017 |
LARSEN & TOUBRO LIMITED |
STELLAR 300 |
04/29/2010 |
K103763 |
LARSEN & TOUBRO LIMITED |
STELLAR 300 |
03/11/2011 |
K042560 |
LARSEN & TOUBRO LIMITED |
STELLAR 404 MONITORING SYSTEM |
10/06/2004 |
K060058 |
LARSEN & TOUBRO LIMITED |
STELLAR 404T |
01/20/2006 |
K160956 |
LD TECHNOLOGY LLC |
LD-Oxi system |
07/06/2016 |
K200141 |
LD Technology LLC |
Oxi-W System |
04/27/2020 |
K130056 |
LD TECHNOLOGY LLC |
PATIENT MONITOR |
04/11/2013 |
K150691 |
Lutech Industries, Inc. |
Datalys Multi-Parameter Patient Monitor |
05/15/2015 |
K071802 |
MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN GMBH |
TESLA GUARD, MODEL EFT G04 |
11/09/2007 |
K052119 |
MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH |
TESLAGUARD, MODEL EFT G04 |
01/03/2006 |
K191882 |
Masimo Corporation |
Masimo Centroid System |
04/22/2020 |
K170168 |
MASIMO CORPORATION |
Masimo Rad-97 and Accessories |
09/14/2017 |
K183697 |
Masimo Corporation |
Masimo Rad-97 and Accessories |
05/15/2019 |
K191059 |
Masimo Corporation |
Masimo Rad-97 and Accessories |
12/27/2019 |
K193626 |
Masimo Corporation |
Masimo Rad-97 Pulse CO-Oximeter and Accessories |
08/10/2020 |
K193242 |
Masimo Corporation |
Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories |
02/27/2020 |
K140188 |
MASIMO CORPORATION |
MASIMO ROOT MONITORING SYSTEM |
06/25/2014 |
K142394 |
MASIMO CORPORATION |
Masimo Root Monitoring System and Accesories |
11/25/2014 |
K153225 |
Masimo Corporation |
Masimo Root Monitoring System and Accessories |
06/21/2016 |
K171121 |
Masimo Corporation |
Masimo Root Monitoring System and Accessories |
11/17/2017 |
K151644 |
MASIMO CORPORATION |
Masimo Root Vital Signs Monitoring System and Accessories |
02/12/2016 |
K212161 |
Masimo Corporation |
Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories |
03/06/2023 |
K004050 |
MATSUSHITA ELECTRIC INDUSTRIAL CO., LTD. |
PANASONIC TELE-HOMECARE SYSTEM |
03/15/2001 |
K131497 |
MCKESSON ISRAEL LTD. |
MCKESSON CARDIOLOGY HEMO |
12/05/2013 |
K143304 |
Medical Informatics Corp |
Sickbay Clinical Platform |
05/26/2015 |
K230214 |
Medopad Inc |
Huma RPM (RPM) |
06/02/2023 |
K212975 |
MedWand Solutions, Inc. |
MedWand |
07/22/2022 |
K161909 |
Midmark Corporation |
IQvitals Zone |
11/17/2016 |
K072516 |
MIDMARK DIAGNOSTICS GROUP |
MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR |
10/18/2007 |
K132038 |
MINDRAY NORTH AMERICA |
ACCUTORR 7 VITAL SIGNS MONITOR |
05/02/2014 |
K132037 |
MINDRAY NORTH AMERICA |
VITAL SIGNS MONITOR |
05/16/2014 |
K153739 |
MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN |
MRI Patient Monitor TeslaDUO |
06/28/2016 |
K142032 |
MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN |
MRI PATIENT MONITORING SYSTEM TESLA M3 |
05/07/2015 |
K031863 |
MOTION MEDIA TECHNOLOGY INC. |
CARESTATION 126S VIDEOPHONE |
10/10/2003 |
K201635 |
MultiSensor Diagnostics (dba Aidar Health) |
MouthLab Vital Signs Monitoring System |
02/06/2021 |
K010424 |
NEXAN LTD |
NEXAN SYSTEM, MODEL NX-301 |
09/04/2001 |
K032749 |
NIHON KOHDEN AMERICA, INC. |
BEDSIDE MONITOR, MODEL OPV-1500 |
09/16/2003 |
K190468 |
Nihon Kohden Corporation |
Nihon Kohden SVM-7200 Series Vital Signs Monitor |
05/28/2019 |
K132033 |
NOBLITT & RUELAND |
BM3/BM3 PLUS |
12/04/2013 |
K000404 |
NORAV MEDICAL LTD. |
PC ECG 1200 |
11/22/2000 |
K080141 |
NORAV MEDICAL LTD. |
PC ECG 1200W SYSTEM |
04/25/2008 |
K110463 |
NORAV MEDICAL LTD. |
PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) |
11/10/2011 |
K130234 |
NUVON, INC. |
NUVON VITALS CHARTING SYSTEM |
03/13/2013 |
K071606 |
OBS MEDICAL |
BIOSIGN CENTRAL STATION |
08/31/2007 |
K071645 |
OMRON HEALTHCARE, INC. |
MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S |
07/02/2007 |
K082812 |
OMRON HEALTHCARE, INC. |
OMRON MODEL HBP-2070 VITAL SIGNS MONITOR |
10/22/2008 |
K220117 |
Ordinatrum Solutions |
ARC Intensive Care Information System (ARC System) |
06/06/2023 |
K053112 |
OXFORD BIOSIGNALS LIMITED |
BIOSIGN |
01/31/2006 |
K183370 |
PeraHealth, Inc. |
PeraMobile and PeraWatch |
09/11/2019 |
K172959 |
PeraHealth, Inc. |
PeraServer and PeraTrend |
05/01/2018 |
K093177 |
PHILIPS MEDICAL SYSTEMS |
INTELLIBRIDGE SYSTEM |
12/18/2009 |
K022920 |
PHILIPS MEDICAL SYSTEMS |
M2376A DEVICELINK SYSTEM |
09/17/2002 |
K033680 |
PHILIPS MEDICAL SYSTEMS |
M2376A PHILIPS DEVICE LINK SYSTEM |
12/11/2003 |
K021347 |
PHILIPS MEDICAL SYSTEMS |
MODIFICATION TO M2376A DEVICELINK SYSTEM |
05/07/2002 |
K041401 |
PHILIPS MEDICAL SYSTEMS |
MODIFICATION TO M2376A DEVICELINK SYSTEM |
06/04/2004 |
K181311 |
Philips Medical Systems Nederlands B.V. |
Philips Hemodynamic Application R1.0 |
09/07/2018 |
K021912 |
PHILIPS MEDICAL SYSTEMS, INC. |
M2376 DEVICELINK SYSTEM |
06/24/2002 |
K030731 |
PHILIPS MEDICAL SYSTEMS, INC. |
M2376A DEVICELINK SYSTEM |
03/21/2003 |
K014181 |
PHILIPS MEDICAL SYSTEMS, INC. |
M2376A DEVICELINK SYSTEM, MODEL M2376A |
01/15/2002 |
K013470 |
PHILIPS MEDICAL SYSTEMS, INC. |
MODIFICATION TO M2376A DEVICELINK SYSTEM |
11/14/2001 |
K020494 |
PHILIPS MEDICAL SYSTEMS, INC. |
MODIFICATION TO M2376A DEVICELINK SYSTEM |
02/21/2002 |
K041942 |
PHILLIPS MEDICAL SYSTEMS |
M2376A DEVICELINK SYSTEM |
07/23/2004 |
K040969 |
POISE TECHNOLOGY CORPORATION |
POISE DATAENGINE |
06/08/2004 |
K101264 |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
TEMPUS IC PROFESSIONAL PATIENT MONITOR |
05/11/2010 |
K134014 |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) |
08/12/2014 |
K133988 |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
TEMPUS PRO EXTENDED FEATURES |
05/16/2014 |
K130773 |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
TEMPUS PRO PATIENT MONITOR |
06/05/2013 |
K113105 |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
TEMPUSIC PATIENT MONITOR |
12/15/2011 |
K152124 |
REMOTE DIAGNOSTICS TECHNOLOGIES LTD |
Tempus IC2 |
10/28/2015 |
K170538 |
Rudolf Riester GmbH |
RVS-100 Vital Signs Monitor |
10/17/2017 |
K023195 |
SCHILLER MEDICAL S.A. |
MAGLIFE C/MAGLIFE C PLUS |
06/03/2003 |
K100394 |
SHANGHAI 3F ELECTRONICS CO LTD |
MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A |
04/15/2010 |
K113183 |
SHANGHAI 3F ELECTRONICS CO LTD |
PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 |
02/09/2012 |
K123711 |
SHENZHEN CREATIVE INDUSTRY CO., LTD |
PATIENT MONITOR |
10/01/2013 |
K170047 |
Shenzhen Creative Industry Co., Ltd. |
All-in-One Health Monitor, PC-303 |
09/09/2017 |
K221113 |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor |
12/02/2022 |
K043348 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
MODIFICATION TO PM-8000 PATIENT MONITOR |
01/06/2005 |
K053193 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS |
05/18/2006 |
K053234 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
PM-9000 EXPRESS PATIENT MONITOR |
05/04/2006 |
K211475 |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Vital Signs Monitors |
10/05/2021 |
K063055 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
VS-800 VITAL SIGNS MONITOR |
12/21/2006 |
K182821 |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Accutorr 7/VS-900/VS-900c Vital Signs Monitor |
03/27/2019 |
K221267 |
Shenzhen Mindray Bio-Meidcal Electronics Co., LTD |
VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor |
12/15/2022 |
K170712 |
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. |
Accutorr 7/VS-900 Vital Signs Monitor |
08/02/2017 |
K061590 |
SIEMENS MEDICAL SOLUTIONS HEALTH SERVICES CORPORAT |
SMDIE DEVICE INTERFACING SYSTEM |
06/21/2006 |
K151512 |
SKANRAY TECHNOLOGIES PRIVATE LIMITED |
Star 60 |
02/14/2016 |
K172147 |
Skanray Technologies Pvt Ltd |
STAR 65 |
05/25/2018 |
K150512 |
SKANRAY TECHNOLOGIES PVT LTD. |
STAR 90 |
06/17/2015 |
K093422 |
SOMANETICS CORP. |
VITAL SYNC MODEL 5000 SERIES |
04/29/2010 |
K133586 |
SOTERA WIRELESS, INC |
VISI MOBILE MONITIORING SYSTEM |
12/18/2013 |
K152341 |
SOTERA WIRELESS, INC |
ViSi Mobile Monitoring System |
12/14/2015 |
K112478 |
SOTERA WIRELESS, INC |
VISI MOBILE MONITORING SYSTEM |
03/22/2012 |
K122036 |
SOTERA WIRELESS, INC |
VISI MOBILE MONITORING SYSTEM |
08/15/2012 |
K130709 |
SOTERA WIRELESS, INC |
VISI MOBILE MONITORING SYSTEM |
10/07/2013 |
K143751 |
Sotera Wireless, Inc. |
Visi Mobile Monitoring System |
01/23/2015 |
K150361 |
Sotera Wireless, Inc. |
ViSi Mobile Monitoring System |
04/30/2015 |
K183634 |
Stasis Labs, Inc. |
Stasis Monitoring System |
04/17/2019 |
K101259 |
TaiDoc Technology Corporation |
V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002 |
06/17/2010 |
K172221 |
TaiDoc Technology Corporation |
VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 |
06/06/2018 |
K073094 |
TELEMEDIC SYSTEMS LTD |
VITALLINK3 MOBILE VITAL SIGNS SYSTEM |
01/04/2008 |
K010732 |
TELEMEDIC SYSTEMS, INC. |
VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM) |
09/27/2001 |
K142087 |
toSense, Inc. |
COVA MONITORING SYSTEM |
05/01/2015 |
K160899 |
TOSENSE, INC. |
CoVa Monitoring System 2 |
06/22/2017 |
K150869 |
Viatom Technology Co., Ltd. |
Checkme Pro Health Monitor |
12/10/2015 |
K172965 |
Visiomed Technology Co.,Ltd |
Handheld VitalSigns Monitoring System |
12/17/2018 |
K060712 |
VISUAL TELECOMMUNICATIONS NETWORK, INC. |
VITELCARE C-TURTLE PATIENT MONITORING SYSTEM |
04/19/2006 |
K043368 |
VISUAL TELECOMMUNICATIONS NETWORK, INC. |
VITELCARE TURTLE, MODEL 400 |
02/01/2005 |
K030419 |
VITERION TELEHEALTHCARE LLC |
VITERION 100 TELEHEALTH MONITOR |
11/06/2003 |
K210086 |
VoCare, Inc. |
Vitals360 Multi-Vitals Mobile Monitor |
05/20/2021 |
K063419 |
WELCH ALLYN PROTOCOL, INC. |
MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) |
12/04/2006 |
K033378 |
WELCH ALLYN PROTOCOL, INC. |
VITAL SIGNS MONITOR, PROPAQ LT |
03/01/2004 |
K142356 |
WELCH ALLYN, INC. |
Connex Spot Monitor,901058 Vital Signs Monitor Core |
12/19/2014 |
K110516 |
WELCH ALLYN, INC. |
CONNEX VITAL SIGNS MONITOR 6000 SERIES |
06/01/2011 |
K121013 |
WELCH ALLYN, INC. |
CONNEX VITAL SIGNS MONITOR 6000 SERIES |
07/26/2012 |
K120343 |
WELCH ALLYN, INC. |
CONNEX WORKSTATION |
02/24/2012 |
K112687 |
WELCH ALLYN, INC. |
CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES |
11/22/2011 |
K132807 |
WELCH ALLYN, INC. |
MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) |
01/31/2014 |
K101445 |
WELCH ALLYN, INC. |
VITAL SIGNS MONITOR-VSM 6000 SERIES |
06/08/2010 |
K132808 |
WELCH ALLYN, INC. |
VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR |
11/20/2013 |
K053027 |
WELCH ALLYN, INC. |
VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) |
11/22/2005 |
K212473 |
Welch Allyn, Inc. |
Welch Allyn Connex Central Station |
10/28/2022 |
K001265 |
WELCH ALLYN, INC. |
WELCH ALLYN INSTRUMENT INTERFACE MODULE |
07/13/2000 |
K033030 |
WITT BIOMEDICAL CORP |
CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM |
02/24/2004 |
K063547 |
WITT BIOMEDICAL CORP |
CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM |
12/21/2006 |
K101571 |
WITT BIOMEDICAL CORP |
XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS |
10/26/2010 |
K063840 |
WITT BIOMEDICAL CORP |
XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION |
02/06/2007 |
K200160 |
Zoe Medical, Inc. |
740 SafeSAT |
02/15/2021 |
K130740 |
ZOE MEDICAL, INC. |
NIGHTINGALE MONITORING SYSTEM |
07/23/2013 |
K202375 |
ZOLL Medical Corporation |
ZOLL Propaq M |
03/09/2021 |