ClearanceBrief
Panels › Cardiovascular › Product code DXN · Class 2

System, Measurement, Blood-Pressure, Non-Invasive

Regulation 870.1130

30510(k)s in 12 months (1,226 all time)
0recalls in 12 months (36 all time)
33recalls that name a 510(k)
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Top companies in DXN

Company510(k)sRecalls
Andon Health Co, Ltd.680
Health & Life Co., Ltd.550
OMRON Healthcare, Inc.370
Microlife Intellectual Property GmbH330
A&D Engineering, Inc.250
Grandway Technology (Shenzhen) Limited210
Nihon Seimitsu Sokki Co., Ltd.180
Welch Allyn, Inc.123
Guangdong Transtek Medical Electronics Co., Ltd.140
JOYTECH Healthcare Co., Ltd.140
Decided510(k)Device and applicantCode
Oct 22, 2012K122482TRANSTEK WRIST BLOOD PRESSURE MONITOR
Zhongshan Transtek Electronics Co., Ltd., CN
DXN
Sep 10, 2012K121372FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Andon Health Co, Ltd., CN
DXN
Aug 29, 2012K121932HEM-7200-Z (BP742)
Omron Healthcare, Inc.
DXN
Aug 17, 2012K121025YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION
Ya Horng Electronic Co., Ltd., TW
DXN
Aug 14, 2012K120320CONNECTED CARE CLINICAL APPLICATION
Watermark Medical, Inc.
DXN
Aug 10, 2012K120554ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
Sejoy Electronics & Instruments Co., Ltd., CN
DXN
Aug 2, 2012K120430MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P
Microlife Intellectual Property GmbH
DXN
Aug 2, 2012K112620DISITAL BLOOD PRESSURE MONITOR
Nihon Seimitsu Sokki Co., Ltd., JP
DXN
Jul 18, 2012K121355WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
Sejoy Electronics & Instruments Co., Ltd., CN
DXN
Jul 3, 2012K120634U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM
Taidoc Technology Corporation, TW
DXN
Jun 14, 2012K121470FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
Andon Health Co, Ltd., CN
DXN
Jun 1, 2012K120672KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR
Andon Health Co, Ltd.
DXN
May 30, 2012K113402SOLOHEALTH STATION
Solohealth, Inc.
DXN
May 15, 2012K121141TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
Tensys Medical Systems, Inc.
DXN
Mar 16, 2012K113239FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)
Health & Life Co., Ltd., TW
DXN
Mar 2, 2012K113264ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)
Ld Technology, LLC
DXN
Mar 1, 2012K113238FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR
Health & Life Co., Ltd., TW
DXN
Feb 24, 2012K112691BLOOD PRESSURE MONITOR
Nihon Seimitsu Sokki Co., Ltd., JP
DXN
Feb 24, 2012K112690BLOOD PRESSURE MONITOR
Nihon Seimitsu Sokki Co., Ltd., JP
DXN
Feb 21, 2012K111141BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR
Wenzhou Bokang Instruments Co., Ltd., CN
DXN
Feb 14, 2012K120144VITAL SIGNS MONITOR
Edan Instruments, Inc., CN
DXN
Feb 14, 2012K120132SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR
Philips Medical Systems
DXN
Feb 10, 2012K112042KINGYIELD WRIST BLOOD PRESSURE MONITOR
Shenzhen Kingyield Technology Co., Ltd., CN
DXN
Jan 31, 2012K120058TRANSTEK BLOOD PRESSURE MONITOR
Zhongshan Transtek Electronics Co., Ltd., CN
DXN
Jan 27, 2012K113185MODEL HBP-1300
Omron Healthcare, Inc.
DXN
Jan 19, 2012K113083TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR
Truly Instrument Co., Ltd.
DXN
Jan 18, 2012K112825AVITA ARM TYPE BLOOD PRESSURE MONITOR
Avita Corporation
DXN
Jan 12, 2012K113085TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR
Truly Instrument Co., Ltd.
DXN
Dec 22, 2011K112216U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM
Taidoc Technology Corporation, TW
DXN
Dec 21, 2011K112521FUKUDA DENSHI VASERA MODEL VS-1500
Fukuda Denshi USA, Inc.
DXN
Dec 21, 2011K112274U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM
Taidoc Technology Corporation, TW
DXN
Dec 16, 2011K110603HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)
I.E.M. GmbH, DE
DXN
Dec 9, 2011K111830FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO
Andon Health Co, Ltd., CN
DXN
Dec 9, 2011K111826FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Andon Health Co, Ltd., CN
DXN
Dec 5, 2011K112845MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
Microlife Intellectual Property GmbH
DXN
Nov 22, 2011K112647BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM
Wistron Corporation, TW
DXN
Nov 22, 2011K112273ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR
Accumed Healthcare (Shanghai), Inc.
DXN
Nov 22, 2011K112270ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR
Accumed Healthcare (Shanghai), Inc.
DXN
Nov 16, 2011K110770HEALTHTRACKER
Wistron Corporation, TW
DXN
Nov 10, 2011K103058MULTIFUNCTION KEITO
Aguiflai Iberica S.L., ES
DXN
Oct 20, 2011K112269OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE
OSTAR MEDITECH CORP., TW
DXN
Oct 11, 2011K112652SURESIGNS VS2+ -SURESIGNS VSI
Philips Medical Systems
DXN
Sep 30, 2011K112320FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
Health & Life Co., Ltd., TW
DXN
Aug 1, 2011K111686A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS
A&D Company, Ltd.
DXN
Jul 27, 2011K110156AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,
Contec Medical System Co., Ltd., CN
DXN
Jul 13, 2011K111652MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR
Microlife Intellectual Property GmbH
DXN
Jul 7, 2011K110044FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM
Foracare, Inc., TW
DXN
May 27, 2011K101681TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
Zhongshan Transtek Electronics Co., Ltd., CN
DXN
May 20, 2011K111114SURESIGNS VS2 VITAL SIGNS MONITOR
Philips Medical Systems
DXN
May 20, 2011K110872WITHINGS BLOOD PRESSURE MONITOR
Withings, TW
DXN

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