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
Mar 24, 2014K133125WITHINGS BLOOD PRESURE MONITOR
Withings, FR
DXN
Mar 11, 2014K131916BPROSOFT CASP PC SOFTWARE
Healthstats International Pte. , Ltd.
DXN
Mar 5, 2014K133619DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES
Grandway Technology (Shenzhen) Limited, CN
DXN
Mar 5, 2014K133618DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES
Grandway Technology (Shenzhen) Limited, CN
DXN
Mar 4, 2014K133383HEM-7320
Omron Healthcare, Inc.
DXN
Mar 4, 2014K131788HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE
Healthstats International Pte. , Ltd.
DXN
Jan 17, 2014K131245OREGON SCINTIFIC
Idt Technology Limited, CN
DXN
Jan 16, 2014K133379HEM-7311
Omron Healthcare, Inc.
DXN
Dec 24, 2013K130325ARM AUTOMATIC BLOOD PRESSURE MONITOR
Shenzhen Pump Medical System Co., Ltd., CN
DXN
Dec 16, 2013K132240DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES
Grandway Technology (Shenzhen) Limited, CN
DXN
Nov 14, 2013K131026BOSCH BLOOD PRESSURE METER (BP5000 BT)
Robert Bosch Healthcare Systems, Inc.
DXN
Oct 23, 2013K132627AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
Honsun (Nantong) Co., Ltd., CN
DXN
Oct 7, 2013K131749HEM-6221
Omron Healthcare, Inc.
DXN
Sep 17, 2013K130232ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM
Jinxinbao Electronic Co.,Ltd, CN
DXN
Sep 17, 2013K123130ANSWATCH WRIST MONITOR MODEL TS-0411
Taiwan Scientific Corporation, TW
DXN
Sep 12, 2013K130925AUTOMATIC BLOOD PRESSURE MONITOR
Honsun (Nantong) Co., Ltd., CN
DXN
Sep 4, 2013K131064BIOSPACE
Biospace Corporation Limited
DXN
Aug 30, 2013K131558PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6
Shenzhen Pango Electronic Co., Ltd., CN
DXN
Aug 14, 2013K123882AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR
Ageless Health Industrial, CN
DXN
Jul 24, 2013K131742HEM-6131
Omron Healthcare, Inc.
DXN
Jul 19, 2013K131203IHEALTH CLOUD
Andon Health Co, Ltd., CN
DXN
Jul 8, 2013K131463WRIST AUTOMATIC BLOOD PRESSURE MONITOR
Honsun (Nantong) Co., Ltd., CN
DXN
Jun 19, 2013K131395TRANSTEK BLOOD PRESSURE MONITOR
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Jun 19, 2013K130564FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
Health & Life Co., Ltd., TW
DXN
Jun 18, 2013K130563FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
Health & Life Co., Ltd., TW
DXN
Jun 14, 2013K131569PG-800A SERIES
Shenzhen Pango Electronic Co., Ltd., CN
DXN
Jun 6, 2013K131346MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
Microlife Intellectual Property GmbH
DXN
May 29, 2013K131121FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
Health & Life Co., Ltd., TW
DXN
May 15, 2013K123800WRIST AUTOMATIC BLOOD PRESSURE MONITOR
Little Doctor Electronic (Nantong)Co.,Ltd, CN
DXN
May 13, 2013K122013MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M)
Microlife Corp.
DXN
May 3, 2013K123600DIGITAL BLOOD PRESSURE MONITOR
Little Doctor Electronic (Nantong)Co.,Ltd, CN
DXN
Apr 22, 2013K123539STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK
Stayhealthy, Inc.
DXN
Apr 22, 2013K122381NEXFIN MODEL 2
Edwards Lifesciences, LLC
DXN
Apr 15, 2013K122076PERSONAL HEALTH CENTER (PHC)
Adflow Health Networks, Inc.
DXN
Mar 21, 2013K123498BP652N (HEM-6300-Z)
Omron Healthcare, Inc.
DXN
Mar 21, 2013K122098APPS-HEALTH01
Andon Health Co, Ltd., CN
DXN
Mar 11, 2013K123073DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0
Grandway Technology (Shenzhen) Limited, CN
DXN
Mar 1, 2013K123780TRANSTEK BLOOD PRESSURE MONITOR
Zhongshan Transtek Electronics Co., Ltd., CN
DXN
Feb 14, 2013K120675DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES
Grandway Technology (Shenzhen) Limited, CN
DXN
Feb 14, 2013K120673DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES
Grandway Technology (Shenzhen) Limited, CN
DXN
Feb 8, 2013K122810COMPACT DIGITAL BLOOD PRESSURE MONITOR
Thermor , Ltd., CA
DXN
Jan 11, 2013K123839WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200
Ningbo Diaier Electronic Co., Ltd., CN
DXN
Dec 21, 2012K123669TRANSTEK WRIST BLOOD PRESSURE MONITOR
Zhongshan Transtek Electronics Co., Ltd., CN
DXN
Dec 11, 2012K121266CARDIOSCOPE
Pulsecor Limited
DXN
Dec 7, 2012K123446TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
United States Gtm Medical Devices, Inc.
DXN
Nov 28, 2012K123020BLIP MODEL BP-700WF
Carematix, Inc.
DXN
Nov 20, 2012K122443UFIT TEN-10
Biosign Technologies, Inc.
DXN
Nov 16, 2012K122129SPHYGMOCOR XCEL
Atcor Medical, AU
DXN
Nov 2, 2012K122401TANGO M2 BLOOD PRESSURE MONITOR
Suntech Medical, Inc.
DXN
Oct 23, 2012K120545HX-461
Seers Technology Co., Ltd.
DXN

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