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
Jun 14, 2001K011523ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138
Rossmax International , Ltd., TW
DXN
Jun 11, 2001K010751BPFONE, MODEL UA 767IT
Medical Monitors Pty Limited, AU
DXN
Jun 8, 2001K010186WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
Welch Allyn, Inc.
DXN
May 31, 2001K011152VASOTRAC APM205A
Medwave, Inc.
DXN
May 16, 2001K003732BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES
Braun GmbH
DXN
Mar 29, 2001K010828DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP
A&D Engineering, Inc.
DXN
Mar 29, 2001K010622PRESSURE TRAK, MODEL 222-B
Suntech Medical Instruments, Inc.
DXN
Mar 20, 2001K010498WRISTWATCH BLOOD PRESSURE MONITOR A46
Rossmax Internationl , Ltd., TW
DXN
Mar 19, 2001K002665WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120
K-Jump Health Co., Ltd.
DXN
Feb 8, 2001K010190WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43
Rossmax Internationl , Ltd., TW
DXN
Jan 29, 2001K002791NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
Unix Electronic Co. , Ltd.
DXN
Jan 29, 2001K001543BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520
Welch Allyn, Inc.
DXN
Dec 15, 2000K003711AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P
Sein Electronics Co., Ltd., KR
DXN
Nov 21, 2000K003444MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR
Nihon Seimitsu Sokki Co., Ltd.
DXN
Nov 14, 2000K002530WELCH ALLYN SPOT CHECK DEVICE
Welch Allyn, Inc.
DXN
Nov 1, 2000K003282FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H
Sein Electronics Co., Ltd., KR
DXN
Nov 1, 2000K001948CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM
Hypertension Diagnostics, Inc.
DXN
Oct 25, 2000K003004OSCAR 2, MODEL 222
Suntech Medical Instruments, Inc.
DXN
Oct 13, 2000K002882HL168B
Health & Life Co., Ltd., TW
DXN
Sep 26, 2000K001244BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D
Citizen Watch Co., Ltd.
DXN
Sep 21, 2000K002248DINAMAP PRO 1000 MONITOR, MODEL 1000
Critikon Company, LLC
DXN
Sep 21, 2000K002029ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION
Zoll Medical Corp
DXN
Sep 18, 2000K002750HL168T
Health & Life Co., Ltd., TW
DXN
Sep 11, 2000K002722DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505
Jawon Medical Co., Ltd., KR
DXN
Sep 6, 2000K002655DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550
Meditec Co., Ltd., KR
DXN
Aug 31, 2000K001898VASOTRAX
Medwave, Inc.
DXN
Aug 25, 2000K002388EHC500 DESKTOP PATIENT STATION, MODEL EHC500
Cybercare, Inc.
DXN
Aug 1, 2000K001182MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1
Microlife Corp.
DXN
Jul 25, 2000K002115A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS
A&D Engineering, Inc.
DXN
Jul 21, 2000K002046MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
Vsm Technology, Inc.
DXN
Jul 3, 2000K001848OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907
Omron Healthcare, Inc.
DXN
Jun 30, 2000K001671ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630
Omron Healthcare, Inc.
DXN
Jun 30, 2000K001670AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757
Omron Healthcare, Inc.
DXN
Jun 13, 2000K000237EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION
Cybercare, Inc.
DXN
Jun 9, 2000K993316UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE
Ueda Avancer Corp.
DXN
May 26, 2000K000500DINAMAP ADVANCED NIBP MODULE
Critikon Company, LLC
DXN
Apr 10, 2000K991458MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254
Matsushita Electric Corp. of America
DXN
Mar 28, 2000K994423AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
Vsm Medtech , Ltd.
DXN
Mar 15, 2000K993938THE HOMMED SENTRY, MODEL 1 SENTRY
Hommed, LLC
DXN
Mar 14, 2000K000675MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502
Jawon Medical Co., Ltd.
DXN
Jan 18, 2000K984083MULTIFUNCTION KEITO K5
Bumedco Intl., Inc.
DXN
Jan 11, 2000K993460ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43
Rossmax International , Ltd., TW
DXN
Jan 7, 2000K993429ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40
Rossmax International , Ltd., TW
DXN
Jan 7, 2000K993426ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44
Rossmax International , Ltd., TW
DXN
Dec 29, 1999K993542ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46
Rossmax International , Ltd., TW
DXN
Dec 20, 1999K993888A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS
A&D Engineering, Inc.
DXN
Dec 20, 1999K993432ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46
Rossmax International , Ltd., TW
DXN
Dec 3, 1999K990807HL148 & HL168
Health & Life Co., Ltd., TW
DXN
Dec 1, 1999K993890DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181
Nihon Seimitsu Sokki Co., Ltd.
DXN
Oct 15, 1999K992478PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
Hewlett-Packard, Healthcare Solutions Group
DXN

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