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
Dec 16, 2015K150908XM-01 Electronic Automatic Blood Pressure Monitor
Sky Innovation Technology ( Shanghai) Limited, CN
DXN
Dec 8, 2015K151127higi Station
Higi Sh, LLC
DXN
Nov 9, 2015K152426Wrist - Type Fully Automatic Digital Blood Pressure Monitor
Sejoy Electronics & Instruments Co., Ltd., CN
DXN
Oct 21, 2015K152770ProBP 2400 Digital Blood Pressure Device
Microlife Intellectual Property GmbH, CH
DXN
Oct 21, 2015K151415Oregon Scientific
Idt Technology Limited, CN
DXN
Oct 16, 2015K152687Arm-Type Fully Automatic Digital Blood Pressure Monitor
Sejoy Electronics & Instruments Co., Ltd., CN
DXN
Sep 29, 2015K152483Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series
Grandway Technology (Shenzhen) Limited, CN
DXN
Sep 24, 2015K152003iHealth BP3L Wireless Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN
Sep 23, 2015K152379iHealth View BP7S Wireless Blood Pressure Wrist Monitor
Andon Health Co, Ltd., CN
DXN
Sep 8, 2015K151460Fully Automatic Electronic Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN
Sep 2, 2015K151869Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property GmbH, Switzerland, CH
DXN
Aug 18, 2015K150311Full Automatic (NIBP)Blood Pressure Monitor
Health & Life Co., Ltd., TW
DXN
Aug 7, 2015K151587Digital Automatic Wrist Blood Pressure Monitor MD3200
Grandway Technology (Shenzhen) Limited, CN
DXN
Aug 7, 2015K151583Digital Automatic Wrist Blood Pressure Monitor MD3900
Grandway Technology (Shenzhen) Limited, CN
DXN
Jul 23, 2015K143735Digital Automatic Blood Pressure Monitor MD2300
Grandway Technology (Shenzhen) Limited, CN
DXN
Jul 14, 2015K151330Microlife Wrist Watch Blood Pressure Monitor
Microlife Intellectual Property GmbH, Switzerland, CH
DXN
Jul 2, 2015K140762AUTOMATIC BLOOD PRESSURE MONITOR
Jawon Medical Co., Ltd., KR
DXN
Jun 30, 2015K151281AGE Automatic Wrist Blood Pressure Monitor
Dongguan Ageless Health Industrial Co., Ltd., CN
DXN
Jun 11, 2015K150373Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0]
Grandway Technology (Shenzhen) Limited, CN
DXN
May 2, 2015K143734Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810
Grandway Technology (Shenzhen) Limited, CN
DXN
Apr 29, 2015K141984FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Andon Health Co, Ltd., CN
DXN
Apr 21, 2015K143341Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property GmbH, CH
DXN
Apr 17, 2015K150430Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor
Fudakang Industrial Co., Ltd., CN
DXN
Apr 10, 2015K140360HEALTH KIOSK
Engagementhealth, LLC
DXN
Apr 3, 2015K143733Digital Automatic Wrist Blood Pressure Monitor MD2400
Grandway Technology (Shenzhen) Limited, CN
DXN
Apr 3, 2015K141683ELECTRONIC BLOOD PRESSURE MONITOR
Shenzhen Urion Technology Co., Ltd., CN
DXN
Apr 2, 2015K150545Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312,
Sejoy Electronics & Instruments Co., Ltd., CN
DXN
Mar 27, 2015K143108HealthGuard-15
Futrex, Inc.
DXN
Mar 20, 2015K141460FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR
Finapres Medical Systems B.V., NL
DXN
Dec 19, 2014K142968Full Automatic (NIBP) Blood Pressure Monitor
Health & Life Co., Ltd., TW
DXN
Dec 1, 2014K142917BP652N (HEM-6300-Z)
Omron Healthcare, Inc.
DXN
Nov 25, 2014K133989AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
Mortara Instrument, Inc.
DXN
Nov 19, 2014K141755ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
Sejoy Electronics & Instruments Co., Ltd., CN
DXN
Oct 31, 2014K142088DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES
Grandway Technology (Shenzhen) Limited, CN
DXN
Oct 9, 2014K141416BLOOD PRESSURE MONITOR
Shenzhen Pump Medical System Co., Ltd., CN
DXN
Oct 8, 2014K141201A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR
A & D Co., Ltd.
DXN
Oct 7, 2014K141160A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR
A & D Co., Ltd.
DXN
Sep 26, 2014K141113SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE
Spacelabs Healthcare, Ltd.
DXN
Sep 15, 2014K140928ABPM7100
I.E.M. GmbH, DE
DXN
Sep 8, 2014K141924HD BLOOD PRESSURE MONITOR
Biocare Asia Corporation , Ltd., CN
DXN
Aug 22, 2014K141083MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR
Microlife Intellectual Property GmbH
DXN
Jul 25, 2014K134029BELTER BLOOD PRESSURE METER
Shenzhen Belter Health Measurement and Analysis TE, CN
DXN
Jul 2, 2014K140572MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
Microlife Intellectual Property GmbH, Switzerland
DXN
Jul 2, 2014K140121FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Andon Health Co, Ltd., CN
DXN
Jun 27, 2014K141179A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR
A & D Co., Ltd.
DXN
Jun 18, 2014K140583DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES
Grandway Technology (Shenzhen) Limited, CN
DXN
Jun 18, 2014K140067QARDIOARM
Qardio, Inc.
DXN
Jun 13, 2014K140312EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
Edwards Lifesciences, LLC
DXN
May 22, 2014K140412ANS1 SOFTWARE
Ld Technology, LLC
DXN
Apr 25, 2014K133588FORA CARE BLOOD PRESSURE MONITORING SYSTEM
Foracare, Inc., TW
DXN

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