FDA 510(k) Applications for Medical Device Product Code "DXN"
(System, Measurement, Blood-Pressure, Non-Invasive)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K141160 | A & D CO., LTD. | A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR | 10/07/2014 |
| K141201 | A & D CO., LTD. | A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR | 10/08/2014 |
| K141179 | A & D CO., LTD. | A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR | 06/27/2014 |
| K032499 | A & D ENGINEERING, INC. | A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS | 10/30/2003 |
| K012472 | A & D ENGINEERING, INC. | A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS | 02/15/2002 |
| K040371 | A & D ENGINEERING, INC. | A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR | 05/19/2004 |
| K061456 | A & D ENGINEERING, INC. | A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR | 06/21/2006 |
| K993888 | A & D ENGINEERING, INC. | A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS | 12/20/1999 |
| K960319 | A & D ENGINEERING, INC. | A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITOR | 07/02/1996 |
| K040229 | A & D ENGINEERING, INC. | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328 | 03/19/2004 |
| K042967 | A & D ENGINEERING, INC. | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 | 12/03/2004 |
| K002115 | A & D ENGINEERING, INC. | A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS | 07/25/2000 |
| K043217 | A & D ENGINEERING, INC. | A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR | 03/03/2005 |
| K982481 | A & D ENGINEERING, INC. | A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR | 09/25/1998 |
| K062027 | A & D ENGINEERING, INC. | A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR | 01/19/2007 |
| K082734 | A & D ENGINEERING, INC. | A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR | 11/13/2008 |
| K980824 | A & D ENGINEERING, INC. | A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR | 03/19/1998 |
| K010828 | A & D ENGINEERING, INC. | DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP | 03/29/2001 |
| K012013 | A & D ENGINEERING, INC. | LIFESOURCE MODELS UA-787, UA 787PC, UA-787T | 07/13/2001 |
| K040410 | A C COSSOR & SON (SURGICAL) LIMITED | GREENLIGHT 300 | 05/05/2004 |
| K173065 | A&D Company, Ltd | A&D Medical Blood Pressure Monitors | 04/24/2019 |
| K151953 | A&D COMPANY, LTD | A&D Medical TM-2657 Family of Digital Blood Pressure Monitors | 04/13/2016 |
| K163683 | A&D COMPANY, LTD | A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor | 05/03/2017 |
| K212168 | A&D Company, Ltd | A&D Medical UM-212BLE Blood Pressure Monitor | 10/06/2022 |
| K111686 | A&D COMPANY, LTD. | A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS | 08/01/2011 |
| K173191 | A&D Company, Ltd. | A&D Medical Blood Pressure Monitors | 03/21/2019 |
| K170196 | A&D Company, Ltd. | A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor | 05/17/2017 |
| K992808 | A&D MEDICAL DIV. | A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE | 09/01/1999 |
| K112273 | ACCUMED HEALTHCARE (SHANGHAI) INC. | ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR | 11/22/2011 |
| K112270 | ACCUMED HEALTHCARE (SHANGHAI) INC. | ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR | 11/22/2011 |
| K222658 | Accurate Meditech Inc. | Accurate 24 Non-invasive blood pressure monitor | 06/21/2023 |
| K060925 | ACON LABORATORIES, INC. | ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112 | 05/09/2006 |
| K122076 | ADFLOW HEALTH NETWORKS INC | PERSONAL HEALTH CENTER (PHC) | 04/15/2013 |
| K162230 | ADON HEALTH CO., LTD. | Fully Automatic Electronic Blood Pressure Monitor | 11/18/2016 |
| K964697 | ADVANCE MEDICAL DEVICE, INC. | AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION | 02/11/1997 |
| K983717 | AEROTEL MEDICAL SYSTEMS (1998) LTD. | BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM | 09/16/1999 |
| K030825 | AEROTEL MEDICAL SYSTEMS (1998) LTD. | MPM-NET | 03/28/2003 |
| K021447 | AEROTEL MEDICAL SYSTEMS (1998) LTD. | TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM | 05/22/2002 |
| K041854 | AEROTEL MEDICAL SYSTEMS, LTD. | MPM SYSTEM | 10/06/2004 |
| K123882 | AGELESS HEALTH INDUSTRIAL | AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR | 08/14/2013 |
| K153552 | Ageless Health Industrial Co., Ltd | AGE Automatic Upper Arm Blood Pressure Monitor | 06/01/2016 |
| K172895 | Ageless Health Industrial Co., Ltd | AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 | 06/18/2018 |
| K103058 | AGUIFLAI IBERICA S.L. | MULTIFUNCTION KEITO | 11/10/2011 |
| K974061 | ALEXANDER MFG. CO. | RECHARGEABLE BATTERY PART NUMBER GL825-200 | 01/16/1998 |
| K180435 | Alicn Medical (Shenzhen), Inc | Arm Blood Pressure Monitor | 01/03/2019 |
| K230649 | Alicn Medical Shenzhen, Inc | Arm Blood Pressure Monitor | 09/07/2023 |
| K210563 | Alicn Medical Shenzhen,Inc | Arm Blood Pressure Monitor | 10/15/2021 |
| K212877 | Alicn Medical Shenzhen,Inc | Arm Blood Pressure Monitor | 01/12/2022 |
| K221913 | Alicn Medical Shenzhen,Inc | Arm Blood Pressure Monitor | 10/12/2022 |
| K952882 | AMERICAN TELECARE, INC. | PERSONAL TELEMEDICINE SYSTEM | 09/09/1996 |
| K012796 | AMLUCK, INC. | AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000 | 03/14/2002 |
| K050413 | AMPLIFE CORPORATION | AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600 | 03/04/2005 |
| K043550 | AMPLIFE CORPORATION | AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 | 01/27/2005 |
| K051903 | ANALOGIC CORPORATION | FETALGARD LITE-NIBP, MODEL FGL-NIBP | 12/27/2005 |
| K122098 | ANDON HEALTH CO., LTD | APPS-HEALTH01 | 03/21/2013 |
| K171282 | Andon Health Co., Ltd | Fully Automatic Blood Pressure Monitor | 07/27/2017 |
| K141984 | ANDON HEALTH CO., LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 04/29/2015 |
| K110018 | ANDON HEALTH CO., LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 03/15/2011 |
| K121372 | ANDON HEALTH CO., LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 09/10/2012 |
| K140121 | ANDON HEALTH CO., LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 07/02/2014 |
| K160563 | ANDON HEALTH CO., LTD | Fully Automatic Electronic Blood Pressure Monitor | 08/04/2016 |
| K160565 | ANDON HEALTH CO., LTD | Fully Automatic Electronic Blood Pressure Monitor | 08/10/2016 |
| K111830 | ANDON HEALTH CO., LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO | 12/09/2011 |
| K121470 | ANDON HEALTH CO., LTD | FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR | 06/14/2012 |
| K131203 | ANDON HEALTH CO., LTD | IHEALTH CLOUD | 07/19/2013 |
| K160014 | Andon Health Co., Ltd | iHealth Track Blood Pressure Monitor | 02/02/2016 |
| K222869 | Andon Health Co., Ltd. | Arm Blood Pressure Monitor | 02/15/2023 |
| K210770 | Andon Health Co., Ltd. | Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor | 07/29/2021 |
| K171062 | Andon Health Co., Ltd. | BP5S Wireless Blood Pressure Monitor | 08/01/2017 |
| K151460 | ANDON HEALTH CO., LTD. | Fully Automatic Electronic Blood Pressure Monitor | 09/08/2015 |
| K162915 | Andon Health Co., Ltd. | Fully Automatic Electronic Blood Pressure Monitor | 02/08/2017 |
| K183534 | Andon Health Co., Ltd. | Fully Automatic Electronic Blood Pressure Monitor | 05/16/2019 |
| K183535 | Andon Health Co., Ltd. | Fully Automatic Electronic Blood Pressure Monitor | 06/04/2019 |
| K210768 | Andon Health Co., Ltd. | Wrist Blood Pressure Monitor, Blood Pressure Monitor | 07/30/2021 |
| K083246 | ANDON HEALTH CO.,LTD | FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961 | 01/29/2009 |
| K083248 | ANDON HEALTH CO.,LTD | FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902 | 01/29/2009 |
| K083247 | ANDON HEALTH CO.,LTD | FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906 | 01/29/2009 |
| K090772 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909 | 06/04/2009 |
| K090770 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905 | 06/04/2009 |
| K090771 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962 | 06/04/2009 |
| K102930 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 11/03/2010 |
| K111826 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 12/09/2011 |
| K163276 | ANDON HEALTH CO.,LTD | Fully Automatic Electronic Blood Pressure Monitor | 05/11/2017 |
| K102690 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 11/24/2010 |
| K102906 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 10/29/2010 |
| K110330 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 02/18/2011 |
| K162668 | ANDON HEALTH CO.,LTD | Fully Automatic Electronic Blood Pressure Monitor | 02/14/2017 |
| K102353 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513 | 09/17/2010 |
| K093452 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971 | 12/23/2009 |
| K093387 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902 | 11/27/2009 |
| K093528 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963 | 12/04/2009 |
| K101950 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930 | 08/31/2010 |
| K102939 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931 | 02/23/2011 |
| K102356 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 | 09/20/2010 |
| K101010 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008 | 07/30/2010 |
| K090963 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 | 04/30/2009 |
| K100014 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557 | 01/29/2010 |
| K083317 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902 | 01/29/2009 |
| K083318 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904 | 01/29/2009 |
| K092588 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918 | 12/29/2009 |
| K100940 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 | 06/29/2010 |
| K083319 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941 | 01/29/2009 |
| K090769 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961 | 06/04/2009 |
| K091997 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962 | 07/30/2009 |
| K090768 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909, | 06/04/2009 |
| K092811 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903 | 01/13/2010 |
| K092045 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739 | 07/30/2009 |
| K092510 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911 | 12/23/2009 |
| K091737 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031 | 08/18/2009 |
| K152003 | ANDON HEALTH CO.,LTD | iHealth BP3L Wireless Blood Pressure Monitor | 09/24/2015 |
| K152379 | ANDON HEALTH CO.,LTD | iHealth View BP7S Wireless Blood Pressure Wrist Monitor | 09/23/2015 |
| K162144 | ANDON HEALTH CO.,LTD | iHealth Wireless Blood Pressure Monitor | 02/01/2017 |
| K080326 | ANDON HEALTH CO.,LTD | KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 07/31/2008 |
| K080319 | ANDON HEALTH CO.,LTD | KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 07/02/2008 |
| K102631 | ANDON HEALTH CO.,LTD | KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 11/04/2010 |
| K120672 | ANDON HEALTH CO.,LTD | KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR | 06/01/2012 |
| K091500 | ANDON HEALTH CO.,LTD | MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 | 07/31/2009 |
| K091738 | ANDON HEALTH CO.,LTD | SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD | 08/18/2009 |
| K091739 | ANDON HEALTH CO.,LTD | SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909 | 08/18/2009 |
| K083395 | ANDON HEALTH CO.,LTD | SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 | 02/27/2009 |
| K102609 | ANDON MEDICAL CO., LTD. | KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 12/09/2010 |
| K040159 | ASIA PACIFIC MICROSYSTEMS, INC. | APM BLOOD PRESSURE MONITOR, MODEL BP108A | 03/22/2004 |
| K221742 | Atcor Medical | CONNEQT PULSE | 04/21/2023 |
| K122129 | ATCOR MEDICAL | SPHYGMOCOR XCEL | 11/16/2012 |
| K012487 | ATCOR MEDICAL PTY. LTD | SPHYGMOCOR PX MODEL SCOR-PX | 02/21/2002 |
| K223905 | Avicena, LLC | Vivio« LVEDP System | 10/06/2023 |
| K210152 | AVICHE Shandong Medical Technology Co, Ltd. | Automatic Digital Blood Pressure Monitor | 09/23/2021 |
| K011779 | AVID CARE CORP. | AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM | 07/13/2001 |
| K010029 | AVID CARE CORP. | HOME HEALTH MONITORING SYSTEM | 06/29/2001 |
| K180155 | Avita Corporation | Arm Type Blood Pressure Monitor | 08/03/2018 |
| K112825 | AVITA CORPORATION | AVITA ARM TYPE BLOOD PRESSURE MONITOR | 01/18/2012 |
| K072137 | AVITA CORPORATION | AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB | 12/07/2007 |
| K030230 | AVITA CORPORATION | AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR) | 05/23/2003 |
| K033397 | AVITA CORPORATION | AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY | 04/09/2004 |
| K102624 | AVITA CORPORATION | AVITA WRIST TYPE BLOOD PRESSURE MONITOR | 12/16/2010 |
| K200346 | Avita Corporation | Wrist Type Blood Pressure Monitor | 12/17/2020 |
| K983796 | BCI INTL., INC. | 6004 NIBP MONITOR WITH TEMPERATURE | 01/22/1999 |
| K984618 | BCI INTL., INC. | BCI MINI-TORR PLUS, MODEL 6004 | 03/25/1999 |
| K970801 | BCI INTL., INC. | BCI MODEL 6004 NIBP MONITOR (6004) | 11/12/1997 |
| K162089 | BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. | Blood Pressure Monitor | 02/10/2017 |
| K093013 | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. | BLOOD PRESSURE MONITOR, MODEL MD200A | 01/08/2010 |
| K141924 | BIOCARE ASIA CORPORATION LTD. | HD BLOOD PRESSURE MONITOR | 09/08/2014 |
| K091414 | BIOCARE CORP. | VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH | 10/21/2009 |
| K081498 | BIOCOMFORT DIAGNOSTICS GMBH & CO. KG | TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205 | 12/17/2008 |
| K083681 | BIOLAND TECHNOLOGY LTD. | BIOLAND BLOOD PRESSURE MONITOR | 01/16/2009 |
| K202934 | Bioland Technology Ltd. | Blood Pressure Monitor | 01/26/2021 |
| K201467 | Bioland Technology Ltd. | Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B | 09/21/2020 |
| K122443 | BIOSIGN TECHNOLOGIES, INC. | UFIT TEN-10 | 11/20/2012 |
| K131064 | BIOSPACE CORPORATION LIMITED | BIOSPACE | 09/04/2013 |
| K021029 | BIOTRAC, INC. | ABP-2000 G-3 | 04/12/2002 |
| K072049 | BMEYE B.V. | CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS | 11/29/2007 |
| K101123 | BMEYE B.V. | NEXFIN MODEL 2 | 10/28/2010 |
| K012035 | BRAUN GMBH | BRAUN PRECISION SENSOR PRO, MODEL BP 2590 | 07/27/2001 |
| K003732 | BRAUN GMBH | BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES | 05/16/2001 |
| K100913 | BRENTWOOD MEDICAL TECHNOLOGY CORP. | IQVITALS AND IQVITALS SYSTEM | 05/26/2010 |
| K984083 | BUMEDCO INTL., INC. | MULTIFUNCTION KEITO K5 | 01/18/2000 |
| K081924 | CALHEALTH INC | CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE | 01/07/2009 |
| K041169 | CANAMET CANADIAN NATL MEDICAL TECHNOLOGIES, INC. | PIESOMETER, MODEL MK-1 | 08/24/2004 |
| K053395 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | BP PRO BLOOD PRESSURE MONITOR | 12/23/2005 |
| K060703 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | PMP4 BP PRO BLOOD PRESSURE MONITOR | 04/04/2006 |
| K043096 | CARDIOCOM | COMMANDER II | 11/24/2004 |
| K053303 | CARDIOCOM LLC | CARDIOCOM COMMANDER III | 12/30/2005 |
| K091821 | CARDIOCOM LLC | COMMANDER 111, MODEL CD300-CD399 | 08/25/2009 |
| K053304 | CARDIOCOM LLC | COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM | 12/30/2005 |
| K123020 | CAREMATIX INC. | BLIP MODEL BP-700WF | 11/28/2012 |
| K031840 | CAREMATIX INC. | CAREMATIX WELLNESS SYSTEM | 10/10/2003 |
| K211588 | Caretaker Medical | Caretaker Platform, VitalStream Platform, CT5 | 08/13/2021 |
| K151499 | CARETAKER MEDICAL, LLC | CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor | 03/18/2016 |
| K163255 | Caretaker Medical, LLC | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor | 04/21/2017 |
| K213699 | Caretaker Medical, LLC | CareTaker Monitor App | 03/30/2022 |
| K982135 | CAS MEDICAL SYSTEMS, INC. | OSCILLOMATE EMS NIBP MONITOR MODEL 9001 | 09/15/1998 |
| K100553 | CITIZEN SYSTEMS JAPAN CO., LTD. | BLOOD PRESSURE METER MODEL CH-101 | 05/25/2010 |
| K093931 | CITIZEN SYSTEMS JAPAN CO., LTD. | BLOOD PRESSURE METER, MODEL CH-4532 | 06/10/2010 |
| K100055 | CITIZEN SYSTEMS JAPAN CO., LTD. | BLOOD PRESSURE METER, MODEL CH-609 | 08/30/2010 |
| K102303 | CITIZEN SYSTEMS JAPAN CO., LTD. | BLOOD PRESSURE METER, MODEL CH-658 | 09/10/2010 |
| K061161 | CITIZEN WATCH CO., LTD. | BLOOD PRESSURE METER, MODEL CH-311B | 06/26/2006 |
| K052046 | CITIZEN WATCH CO., LTD. | BLOOD PRESSURE METER, MODEL CH-432 | 10/19/2005 |
| K984223 | CITIZEN WATCH CO., LTD. | BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471 | 04/28/1999 |
| K001244 | CITIZEN WATCH CO., LTD. | BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D | 09/26/2000 |
| K954547 | CITIZEN WATCH CO., LTD. | CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER | 04/01/1997 |
| K973061 | CITIZEN WATCH CO., LTD. | CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B) | 03/13/1998 |
| K093981 | Cnoga Medical LTD | YRNSORTIP OXIMANOMETER | 07/22/2010 |
| K082599 | CNSYSTEM MEDIZINTECHNIK AG | NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT | 10/17/2008 |
| K183521 | CNSystems Medizintechnik GmbH | CNAP Monitor | 09/11/2019 |
| K223332 | CNSystems Medizintechnik GmbH | Task Force CORE | 04/12/2023 |
| K013434 | COLIN CORP. | VP-2000/1000 | 07/09/2002 |
| K973637 | COLIN MEDICAL INSTRUMENTS CORP. | PRESS-MATE ADVANTAGE | 09/25/1998 |
| K032857 | COLIN MEDICAL INSTRUMENTS CORP. | PRESS-MATE BX-10 VITAL SIGN MONITOR | 02/04/2004 |
| K101198 | COMPUTERIZED SCREENING, INC. | CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K | 08/04/2010 |
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| K993316 | UEDA AVANCER CORP. | UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE | 06/09/2000 |
| K123446 | United States GTM Medical Devices, Inc. | TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM | 12/07/2012 |
| K002791 | UNIX ELECTRONIC CO. LTD. | NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM | 01/29/2001 |
| K011625 | VASOCOR, INC. | VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300) | 01/23/2002 |
| K171668 | Visiomed Group SA | Bluetooth blood pressure monitor | 02/26/2018 |
| K190893 | Vita-Course Technologies Co., Ltd. | Non-invasive Hemodynamic Blood Pressure Monitor | 08/07/2019 |
| K994423 | VSM MEDTECH LTD. | AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 | 03/28/2000 |
| K023055 | VSM MEDTECH LTD. | BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200 | 10/22/2002 |
| K023078 | VSM MEDTECH LTD. | BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR | 03/21/2003 |
| K012636 | VSM TECHNOLOGY, INC. | BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 | 10/26/2001 |
| K002046 | VSM TECHNOLOGY, INC. | MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 | 07/21/2000 |
| K120320 | WATERMARK MEDICAL INC | CONNECTED CARE CLINICAL APPLICATION | 08/14/2012 |
| K001543 | WELCH ALLYN, INC. | BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 | 01/29/2001 |
| K052784 | WELCH ALLYN, INC. | DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900 | 11/22/2005 |
| K021756 | WELCH ALLYN, INC. | WELCH ALLYN ABPM 6100 | 06/27/2002 |
| K010186 | WELCH ALLYN, INC. | WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM | 06/08/2001 |
| K093907 | WELCH ALLYN, INC. | WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE | 04/14/2010 |
| K002530 | WELCH ALLYN, INC. | WELCH ALLYN SPOT CHECK DEVICE | 11/14/2000 |
| K040490 | WELCH ALLYN, INC. | WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE | 08/18/2004 |
| K101680 | WELCH ALLYN, INC. | WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES | 07/09/2010 |
| K024005 | WELCH ALLYN, INC. | WELCH ALLYN VITAL SIGN MONITOR WITH MP506 | 02/12/2003 |
| K023495 | WELCH ALLYN, INC. | WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK) | 10/31/2002 |
| K111141 | WENZHOU BOKANG INSTRUMENTS CO., LTD. | BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR | 02/21/2012 |
| K231542 | Weony (Shenzhen) Technology Co., Ltd. | Digital Blood Pressure Monitor WBP Series | 09/07/2023 |
| K210671 | Weony (Shenzhen) Technology Co., Ltd. | Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 | 08/13/2021 |
| K112647 | WISTRON CORPORATION | BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM | 11/22/2011 |
| K110770 | WISTRON CORPORATION | HEALTHTRACKER | 11/16/2011 |
| K110872 | WITHINGS | WITHINGS BLOOD PRESSURE MONITOR | 05/20/2011 |
| K133125 | WITHINGS | WITHINGS BLOOD PRESURE MONITOR | 03/24/2014 |
| K190982 | Xiamen Ants Bro Technology Co., Ltd. | Automatic Digital Blood Pressure Monitor | 05/29/2020 |
| K063008 | XPEREX CORPORATION | HEALTH CHECK KIOSK | 06/07/2007 |
| K183491 | Xuzhou Yongkang Electronic Science Technology Co., Ltd | Arm Blood Pressure Monitor | 03/24/2019 |
| K162616 | Xuzhou Yongkang Electronic Science Technology Co., Ltd | Wrist Type Blood Pressure Monitor | 03/09/2018 |
| K040528 | YA HORNG ELECTRONIC CO., LTD. | AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T | 04/15/2004 |
| K042581 | YA HORNG ELECTRONIC CO., LTD. | AMLUCK, YA HORNG | 10/13/2004 |
| K051863 | YA HORNG ELECTRONIC CO., LTD. | AMLUCK, YA HORNG | 08/19/2005 |
| K221486 | Ya Horng Electronic Co., Ltd. | INDEX BPM | 08/30/2022 |
| K051862 | YA HORNG ELECTRONIC CO., LTD. | PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR. | 08/23/2005 |
| K081590 | YA HORNG ELECTRONIC CO., LTD. | YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J | 06/19/2008 |
| K121025 | YA HORNG ELECTRONIC CO., LTD. | YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION | 08/17/2012 |
| K072860 | YA HORNG ELECTRONIC CO., LTD. | YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500 | 02/25/2008 |
| K090058 | YA HORNG ELECTRONIC CO., LTD. | YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB | 04/22/2009 |
| K211532 | Yibin Junxin Electronics Technology Co., Ltd. | Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 | 01/19/2022 |
| K070473 | ZEN STRONG MEDICAL TECHNOLOGY CO., LTD | BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX | 05/23/2007 |
| K090027 | ZEN STRONG MEDICAL TECHNOLOGY CO., LTD | BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107 | 02/02/2009 |
| K024077 | ZEWA, INC. | DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR | 03/10/2003 |
| K041491 | ZEWA, INC. | ZEWA MFM-007 BLOOD PRESSURE MONITOR | 09/20/2004 |
| K213023 | Zhangzhou Easepal Medical Science And Technology Co.,LTD | Blood Pressure Monitor(Model:Y30001) | 09/30/2022 |
| K120058 | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. | TRANSTEK BLOOD PRESSURE MONITOR | 01/31/2012 |
| K123780 | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. | TRANSTEK BLOOD PRESSURE MONITOR | 03/01/2013 |
| K101681 | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. | TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 | 05/27/2011 |
| K122482 | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. | TRANSTEK WRIST BLOOD PRESSURE MONITOR | 10/22/2012 |
| K123669 | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. | TRANSTEK WRIST BLOOD PRESSURE MONITOR | 12/21/2012 |
| K220220 | Zhuhai Linte Medical Instrument Co., Ltd. | Electronic Sphygmomanometer (Model: LT-P30) | 10/03/2022 |
| K093802 | ZOE MEDICAL, INC. | ULTRAVIEW DM3 MONITOR | 04/09/2010 |
| K040012 | ZOE MEDICAL, INC. | WELL@HOME SYSTEM | 04/02/2004 |
| K032363 | ZOLL MEDICAL CORP. | ZOLL M SERIES NIBP OPTION | 10/31/2003 |
| K002029 | ZOLL MEDICAL CORP. | ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION | 09/21/2000 |
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