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
Jun 7, 2017K163679Digital Automatic Blood Pressure Monitor MD3600
Grandway Technology (Shenzhen) Limited, CN
DXN
May 24, 2017K162463Matrix Data Management System
Global Instrumentation, LLC
DXN
May 17, 2017K170196A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor
A&D Company, Ltd.
DXN
May 11, 2017K163276Fully Automatic Electronic Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN
May 9, 2017K163606Digital Blood Pressure Monitor-Automatic Upper Arm Style
Shenzhen Combei Technology Co., Ltd., CN
DXN
May 3, 2017K163683A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor
A&D Company, Ltd.
DXN
Apr 21, 2017K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiologica
Caretaker Medical, LLC
DXN
Apr 20, 2017K163235HEM-9210T
Omron Healthcare, Inc.
DXN
Apr 18, 2017K160967Finapres Nova Noninvasive Hemodynamic Monitor
Finapres Medical Systems B.V., NL
DXN
Apr 5, 2017K161712Arm automatic blood pressure monitor
Shenzhen Pump Medical System Co., Ltd., CN
DXN
Mar 31, 2017K161530Bluetooth blood pressure monitor
Shenzhen Kingyield Technology Co., Ltd., CN
DXN
Mar 17, 2017K153600Consult Station TS
H4D Sas, FR
DXN
Feb 21, 2017K163045Omron HEM-6400T-Z Wrist Blood Pressure Monitor
Omron Healthcare, Inc.
DXN
Feb 14, 2017K162668Fully Automatic Electronic Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN
Feb 10, 2017K162089Blood Pressure Monitor
Beijing Choice Electronic Technology Co., Ltd., CN
DXN
Feb 8, 2017K162915Fully Automatic Electronic Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN
Feb 8, 2017K161577Arm-Type Fully Automatic Digital Blood Pressure Monitor
Sejoy Electronics & Instruments Co., Ltd., CN
DXN
Feb 1, 2017K162144iHealth Wireless Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN
Jan 19, 2017K163113Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
Grandway Technology (Shenzhen) Limited, CN
DXN
Nov 22, 2016K162092Evolv Model BP7000 Upper Arm Blood Pressure Monitor
Omron Healthcare, Inc.
DXN
Nov 22, 2016K161708Arm automatic blood pressure monitor
Shenzhen Pump Medical System Co., Ltd., CN
DXN
Nov 18, 2016K162230Fully Automatic Electronic Blood Pressure Monitor
Adon Health Co., Ltd., CN
DXN
Nov 3, 2016K160349Electronic Sphygmomanometer
Guangdong Biolight Meditech Co., Ltd., CN
DXN
Oct 24, 2016K161846Automatic Arm Bluetooth Blood Pressure Monitor
Truly Instrument Limited, CN
DXN
Oct 14, 2016K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure De
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Sep 21, 2016K162338Full Automatic (NIBP) Blood Pressure Monitor
Health & Life Co., Ltd., TW
DXN
Aug 25, 2016K152659V10
Mediana Co., Ltd., KR
DXN
Aug 10, 2016K160565Fully Automatic Electronic Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN
Aug 4, 2016K160563Fully Automatic Electronic Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN
Jul 19, 2016K153557ABPM 7100, Hypertension Management Software
I.E.M. GmbH, DE
DXN
Jul 6, 2016K160557Full Automatic (NIBP) Blood Pressure Monitor
Health & Life Co., Ltd., TW
DXN
Jul 6, 2016K160439SunTech CT40 Spot-check Vital Signs Device
Suntech Medical
DXN
Jun 24, 2016K153033Digital Blood Pressure Monitor
Suzhou Sunspiri Co., Ltd., CN
DXN
Jun 14, 2016K161156Full Automatic (NIBP) Blood Pressure Monitor
Health & Life Co., Ltd., CN
DXN
Jun 1, 2016K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform
Edwards Lifesciences, LLC
DXN
Jun 1, 2016K153552AGE Automatic Upper Arm Blood Pressure Monitor
Ageless Health Industrial Co., Ltd., CN
DXN
May 6, 2016K152415Digital Blood Pressure Monitor
Suzhou Sunspirit Co., Ltd., CN
DXN
Apr 22, 2016K160019U80 Series Upper Arm Electronic Blood Pressure Monitor
Shenzhen Urion Technology Co., Ltd., CN
DXN
Apr 13, 2016K151953A&D Medical TM-2657 Family of Digital Blood Pressure Monitors
A&D Company, Ltd.
DXN
Apr 12, 2016K152107HealthChek Network Health Station
Healthchek Network, LLC
DXN
Mar 29, 2016K160336Full Automatic (NIBP) Blood Pressure Monitor
Health & Life Co., Ltd., CN
DXN
Mar 18, 2016K151499CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor
Caretaker Medical, LLC
DXN
Mar 13, 2016K160145Full Automatic (NIBP) Blood Pressure Monitor
Health & Life Co., Ltd., TW
DXN
Feb 23, 2016K152831Spot Skan
Skanray Technologies Private Limited, IN
DXN
Feb 19, 2016K151520Oscar 2
Suntech Medical, Inc.
DXN
Feb 18, 2016K151258Arm automatic blood pressure monitor
Shenzhen Pump Medical System Co., Ltd., CN
DXN
Feb 12, 2016K153077Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property GmbH, CH
DXN
Feb 2, 2016K160014iHealth Track Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN
Jan 7, 2016K153214Full Automatic (NIBP) Blood Pressure Monitor
Health & Life Co., Ltd., TW
DXN
Dec 16, 2015K153450Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property GmbH, CH
DXN

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