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

Decided510(k)Device and applicantCode
Mar 10, 2003K024077DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR
Zewa, Inc.
DXN
Feb 12, 2003K024005WELCH ALLYN VITAL SIGN MONITOR WITH MP506
Welch Allyn, Inc.
DXN
Jan 14, 2003K023834HL888
Health & Life Co., Ltd., TW
DXN
Dec 12, 2002K021682OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC
Omron Healthcare, Inc.
DXN
Nov 21, 2002K022916BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211
K-Jump Health Co., Ltd.
DXN
Nov 19, 2002K022783TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM
Tensys Medical, Inc.
DXN
Nov 8, 2002K021240EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200
Eikon Healthcare Device Corp., TW
DXN
Nov 8, 2002K021239EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M
Eikon Healthcare Device Corp., TW
DXN
Oct 31, 2002K023495WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)
Welch Allyn, Inc.
DXN
Oct 22, 2002K023055BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200
Vsm Medtech , Ltd., CA
DXN
Sep 13, 2002K014141DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11
Digibio Technology Corp.
DXN
Aug 15, 2002K020537TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM
Tensys Medical, Inc.
DXN
Aug 6, 2002K020897ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400
Rossmax Internationl , Ltd., TW
DXN
Jul 9, 2002K013434VP-2000/1000
Colin Corp., JP
DXN
Jun 28, 2002K021305MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER
Microlife Corp.
DXN
Jun 27, 2002K021756WELCH ALLYN ABPM 6100
Welch Allyn, Inc.
DXN
Jun 17, 2002K021252BLOOD-PRESSURE METER
Idt Technology Limited, HK
DXN
May 22, 2002K021447TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM
Aerotel Medical Systems (1998) , Ltd.
DXN
May 22, 2002K021225ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I
Rossmax International , Ltd., TW
DXN
May 22, 2002K020584N2000 BASE STATION; N2001 NURSE STATION
Neptec Design Group, Ltd.
DXN
Apr 22, 2002K020184HOMMED CENTRAL STATION
Hommed, LLC
DXN
Apr 12, 2002K021029ABP-2000 G-3
Biotrac, Inc.
DXN
Apr 5, 2002K020766HL168F
Health & Life Co., Ltd., TW
DXN
Mar 14, 2002K012796AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000
Amluck, Inc., TW
DXN
Mar 5, 2002K014204ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
K-Jump Health Co., Ltd.
DXN
Feb 21, 2002K012487SPHYGMOCOR PX MODEL SCOR-PX
Atcor Medical Pty, Ltd.
DXN
Feb 15, 2002K012472A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS
A&D Engineering, Inc.
DXN
Jan 23, 2002K011625VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)
Vasocor, Inc.
DXN
Jan 17, 2002K013583ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS
Rossmax International , Ltd., TW
DXN
Jan 17, 2002K013539ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS
Rossmax International , Ltd., TW
DXN
Jan 17, 2002K013485MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1
Microlife Corp.
DXN
Jan 16, 2002K014122HL168E
Health & Life Co., Ltd., TW
DXN
Jan 10, 2002K013478DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM
Pulse Metric, Inc.
DXN
Dec 13, 2001K013358DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM
Pulse Metric, Inc.
DXN
Nov 14, 2001K012801N2000 BASE STATION, N2001 NURSE STATION
Neptec Design Group, Ltd.
DXN
Nov 9, 2001K012647TONOPORT V
Par Medizintechnik GmbH, DE
DXN
Nov 1, 2001K012498DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM
Pulse Metric, Inc.
DXN
Oct 26, 2001K012636BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
Vsm Technology, Inc., CA
DXN
Oct 23, 2001K013033MODIFICATION TO: HL168W TOUCH SCREEN
Health & Life Co., Ltd., TW
DXN
Oct 23, 2001K011058TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII
Meridian Medical Technologies , Ltd., IE
DXN
Aug 22, 2001K012310MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
Health & Life Co., Ltd., TW
DXN
Aug 8, 2001K012054FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
Sein Electronics Co., Ltd., KR
DXN
Jul 27, 2001K012035BRAUN PRECISION SENSOR PRO, MODEL BP 2590
Braun GmbH
DXN
Jul 20, 2001K011539ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS
Rossmax International , Ltd., TW
DXN
Jul 20, 2001K011352ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS
Rossmax International , Ltd., TW
DXN
Jul 20, 2001K011310NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1
Nien Made Electrnics Corp.
DXN
Jul 13, 2001K012013LIFESOURCE MODELS UA-787, UA 787PC, UA-787T
A&D Engineering, Inc.
DXN
Jul 13, 2001K011779AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM
Avid Care Corp.
DXN
Jun 29, 2001K010029HOME HEALTH MONITORING SYSTEM
Avid Care Corp.
DXN
Jun 28, 2001K003180HOMMED OBSERVER, MODEL I
Hommed, LLC
DXN

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