ClearanceBrief
Panels › Cardiovascular › Product code MWJ · Class 2

Electrocardiograph, Ambulatory (Without Analysis)

Regulation 870.2800

5510(k)s in 12 months (64 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
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Top companies in MWJ

Company510(k)sRecalls
Braemar Corp.60
North East Monitoring, Inc.50
Getemed Medizin- Und Informationstechnik AG40
Spacelabs Healthcare, Ltd.22
Braemar Manufacturing, LLC12
Mortara Instrument, Inc.30
Biotricity20
Datrix20
Diagnostic Monitoring Software20
Inovise Medical, Inc.20
Decided510(k)Device and applicantCode
May 16, 2001K003707CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A
Cardionet
MWJ
Dec 13, 2000K003520NEXAN SYSTEM, MODEL NX-300
Nexan, Ltd.
MWJ
Jul 27, 2000K001349CARDIOVISE ECG INTERPRETATIVE SOFTWARE
Inovise Medical, Inc.
MWJ
Jul 21, 2000K001317ARIA
Del Mar Medical Systems, LLC
MWJ
Jul 20, 2000K001288DR180-II
North East Monitoring, Inc.
MWJ
May 23, 2000K000609CARDTEL, MODEL NT-100
Cardiac Telecommunications
MWJ
Jan 13, 2000K992584PE 501 PC-ECG MONITOR
Nhe Corp.
MWJ
Dec 28, 1999K993643NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
Nexan Telemed , Ltd.
MWJ
Nov 24, 1999K993618DXP1000 HOLTER RECORDER
Braemar Corp.
MWJ
Nov 24, 1999K993617DIGITRAKPLUS HOLTER RECORDER
Braemar Corp.
MWJ
Oct 19, 1999K992425TES-20
Tes Electrical Electronic Corp., CN
MWJ
Apr 9, 1999K982617TRACER
Heartland Medical Systems, Inc.
MWJ
Nov 10, 1998K982975DIGITAL ECG HOLTER RECORDER, MODEL DR512
Datrix
MWJ
Nov 10, 1998K982843CMS-2000
Industrial Technology Research Institute, TW
MWJ

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