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
May 16, 2019K173895Tel-O-Graph
I.E.M. Industrielle Entwicklung and Medizintechnik, DE
DXN
May 9, 2019K181894TOF-Cuff monitor
Rgb Medical Devices SA, ES
DXN
Apr 24, 2019K173065A&D Medical Blood Pressure Monitors
A&D Company, Ltd.
DXN
Apr 17, 2019K190693HEM-6410T-ZL Wrist Blood Pressure Monitor
Omron Healthcare, Inc.
DXN
Apr 9, 2019K181832Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Apr 4, 2019K181931GMC Upper Arm Automatic Blood Pressure Monitor
Gmc, Inc., CN
DXN
Mar 24, 2019K183491Arm Blood Pressure Monitor
Xuzhou Yongkang Electronic Science Technology Co., Ltd., CN
DXN
Mar 21, 2019K173191A&D Medical Blood Pressure Monitors
A&D Company, Ltd.
DXN
Mar 14, 2019K182579Omron Model BP7900 Blood Pressure Monitor + EKG
Omron Healthcare, Inc.
DXN
Mar 12, 2019K183469Microlife Digital Blood Pressure Monitor
Microlife Intellectual Property GmbH, CH
DXN
Mar 3, 2019K182495Electronic Blood Pressure Monitor
Shenzhen Jumper Medical Equipment Co., Ltd., CN
DXN
Feb 14, 2019K181930GMC Wrist Automatic Blood Pressure Monitor
Gmc, Inc., CN
DXN
Feb 12, 2019K182934FORA P100 Blood Pressure Monitoring System
Taidoc Technology Corporation, TW
DXN
Jan 3, 2019K180435Arm Blood Pressure Monitor
Alicn Medical (Shenzhen), Inc., CN
DXN
Nov 30, 2018K182245EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System
Edwards Lifesciences, LLC
DXN
Nov 9, 2018K182481HEM-6410T-ZM Wrist Blood Pressure Monitor
Omron Healthcare, Inc.
DXN
Nov 8, 2018K182166Wrist Blood Pressure Monitor Model BP4350
Omron Healthcare, Inc.
DXN
Nov 6, 2018K173916Finapres Nova Noninvasive Hemodynamic Monitor
Finapres Medical Systems B.V., NL
DXN
Nov 2, 2018K182127Wrist Blood Pressure Monitor Model BP6100
Omron Healthcare, Inc.
DXN
Oct 17, 2018K180240Full Automatic(NIBP) Blood Pressure Monitor
Health & Life Co., Ltd., TW
DXN
Oct 6, 2018K182018Bluetooth blood pressure monitor
Shenzhen Kingyield Technology Co., Ltd., CN
DXN
Aug 29, 2018K181104Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style
Shenzhen Combei Technology Co., Ltd., CN
DXN
Aug 22, 2018K173024Non-invasive blood pressure measurement systems
Joytech Healthcare Co. , Ltd., CN
DXN
Aug 3, 2018K180155Arm Type Blood Pressure Monitor
Avita Corporation, TW
DXN
Jun 21, 2018K173028BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
Healthstats International Pte. , Ltd., SG
DXN
Jun 18, 2018K172895AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819
Ageless Health Industrial Co., Ltd., CN
DXN
Apr 18, 2018K172880Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property GmbH, CH
DXN
Apr 10, 2018K171379Digital Automatic Wrist Blood Pressure Monitor MD4300
Grandway Technology (Shenzhen) Limited, CN
DXN
Mar 27, 2018K170605Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE67
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., CN
DXN
Mar 16, 2018K171937Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property GmbH, CH
DXN
Mar 9, 2018K162616Wrist Type Blood Pressure Monitor
Xuzhou Yongkang Electronic Science Technology Co., Ltd., CN
DXN
Mar 2, 2018K172972Wrist Type Automatic Blood Pressure Monitor
Shenzhen Jiacom Technology CO ., Ltd., CN
DXN
Feb 26, 2018K171668Bluetooth blood pressure monitor
Visiomed Group SA, FR
DXN
Feb 21, 2018K170866Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
Honsun (Nantong) Co., Ltd., CN
DXN
Jan 26, 2018K172896Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312
Shenzhen Jiacom Technology CO ., Ltd., CN
DXN
Jan 10, 2018K171833Digital Blood Pressure Monitor-Wrist Style
Shenzhen Combei Technology Co., Ltd., CN
DXN
Dec 15, 2017K170497V10
Mediana Co., Ltd., KR
DXN
Nov 22, 2017K170666The Wrist-Type Fully Automatic Digital Blood Pressure Monitors
Joytech Healthcare Co. , Ltd., CN
DXN
Nov 21, 2017K170545Automatic Wrist Bluetooth Blood Pressure Monitor
Truly Instrument , Ltd., CN
DXN
Oct 27, 2017K170466Automatic Blood Pressure Monitor Model LD-518 & LD-537
Honsun (Nantong) Co., Ltd., CN
DXN
Oct 25, 2017K170454Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U
Honsun (Nantong) Co., Ltd., CN
DXN
Oct 13, 2017K172498Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y
Microlife Intellectual Property GmbH, CH
DXN
Oct 13, 2017K170151Electronic Blood Pressure Monitor
Shenzhen Pango Electronic Co., Ltd., CN
DXN
Oct 10, 2017K172739higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff
Higi Sh, LLC
DXN
Aug 30, 2017K170467Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property GmbH, CH
DXN
Aug 1, 2017K171062BP5S Wireless Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN
Jul 31, 2017K161845Electronic Blood Pressure Monitor
Shenzhen Pango Electronic Co., Ltd., CN
DXN
Jul 27, 2017K171282Fully Automatic Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN
Jul 7, 2017K163648Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series
Grandway Technology (Shenzhen) Limited, CN
DXN
Jun 14, 2017K170966TONOPORT VI
Par Medizintechnik GmbH & Co. KG, DE
DXN

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