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
Sep 11, 2026K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202);
Shenzhen Xinyan Medical Technology Co.,ltd., CN
MWJ
Sep 4, 2026K253529Peerbridge COR MDx (Cor MDx)
Peerbridge Health, Inc.
MWJ
Aug 14, 2026K253562medilogFD
Schiller AG, CH
MWJ
Jun 25, 2026K253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)
Seers Technology Co., Ltd., KR
MWJ
Jun 18, 2026K252839ZywieZ3 Sensor & Adhesive
Zywie, Inc.
MWJ
Dec 13, 2024K231424HeartBeam AIMIGo(TM) System
Heartbeam, Inc.
MWJ
May 7, 2024K233864ASSURE Wearable ECG
Kestra Medical Technologies, Inc.
MWJ
Nov 7, 2022K212317Eclipse MINI Model 98900
Spacelabs Healthcare, Ltd., GB
MWJ
Jul 28, 2022K222017Biotres
Biotricity
MWJ
Jun 2, 2022K210758Q Patch
Medicalgorithmics S.A., PL
MWJ
Jan 19, 2022K211709Biotres
Biotricity
MWJ
Nov 22, 2021K211651Eclipse PRO
Spacelabs Healthcare, Ltd., GB
MWJ
Jun 8, 2018K173156Integrated CardioRespiratory System
Sensydia, Inc.
MWJ
Jun 13, 2016K161062NR Recorder
Norav Medical GmbH, DE
MWJ
Feb 26, 2016K152626H3+ Holter Recorder
Mortara Instrument, Inc.
MWJ
Nov 25, 2014K142424DR300 HOLTER MONITOR
North East Monitoring, Inc.
MWJ
May 19, 2014K133014DMS 300-2W HOLTER ECG RECORDER
Diagnostic Monitoring Software
MWJ
Oct 16, 2013K130294BRAEMAR CARDIOKEY HOLTER RECORDER
Braemar Manufacturing, LLC
MWJ
Jul 26, 2013K130785SEER 1000
Getemed Medizin- Und Informationstechnik AG, DE
MWJ
Mar 28, 2013K122272CARDIOMEM
Getemed Medizin- Und Informationstechnik AG
MWJ
Mar 22, 2012K112573EZSLEEP SLEEP QUALITY RECORDER
Platinum Team Co., Ltd., TW
MWJ
Nov 9, 2011K112601INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER
Intricon Datrix Corporation
MWJ
Feb 4, 2011K101969MH1 MICROHOLTER RECORDER
Exelys, LLC
MWJ
Jan 6, 2011K101024KENZ CARDY302 MAX
Suzuken Co., Ltd.
MWJ
Dec 9, 2010K102723MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS
Memtec Corp.
MWJ
Oct 13, 2010K100310BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS
BTL Industries, Inc.
MWJ
Apr 29, 2010K100266ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603
Camntech, Ltd., GB
MWJ
Aug 13, 2009K083382CHROMA, MODEL: RZ153C
Scottcare Corporation
MWJ
Jul 27, 2009K091054WALK400H
Et Medical Devices Spa, IT
MWJ
Sep 9, 2008K073545AUDICOR, HEMO AMBULATORY MONITOR
Inovise Medical, Inc.
MWJ
Oct 3, 2007K071085E3-80 PORTABLE ECG RECORDER & ANALYZER
Micro-Star International Co., Ltd., TW
MWJ
Jul 24, 2007K071733DL900 SERIES HOLTER RECORDER
Braemar, Inc.
MWJ
May 30, 2007K063042CARDIOMEM CM 3000-12BT
Getemed Medizin- Und Informationstechnik AG
MWJ
May 25, 2007K070014AUTO DETECT FOR TELAHEART DR200/E-A
North East Monitoring, Inc.
MWJ
Apr 27, 2007K071011MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER
Braemar, Inc.
MWJ
Oct 16, 2006K062959DMS 300-2, 300-3 AND 300-4
Diagnostic Monitoring Software
MWJ
Aug 25, 2006K061293TELAHEART DIGITAL RECORDER
North East Monitoring, Inc.
MWJ
Jul 14, 2005K051686CARDIOMEM CM 3000-12
Getemed Medizin- Und Informationstechnik AG
MWJ
May 19, 2005K050731SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM
Ge Medical Systems Information Technologies
MWJ
Feb 25, 2005K043010HOLTER RECORDER H3+
Mortara Instrument, Inc.
MWJ
Oct 6, 2004K042469BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER
Braemar, Inc.
MWJ
Aug 31, 2004K041901SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER
North East Monitoring, Inc.
MWJ
Jan 28, 2004K032882RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100
Recom Managed Systems, Inc.
MWJ
Oct 15, 2003K031074DIGITAL AMBULATORY ECG (HOLTER) RECORDER
Datrix
MWJ
Aug 27, 2003K032276CLICK HOLTER
Remco Italia S.P.A., IT
MWJ
Aug 22, 2003K032466SPIDERVIEW
Ela Medical, Inc.
MWJ
Mar 28, 2003K030856ER800 SERIES ECG EVENT RECORDER
Braemar Corp.
MWJ
Nov 14, 2002K021470SEER LIGHT COMPACT DIGITAL HOLTER RECORDER
General Electric Medical Systems Information Techn
MWJ
Jun 27, 2002K021373H12+HOLTER RECORDER
Mortara Instrument, Inc.
MWJ
Jul 13, 2001K011837LIFECARD CF 7 DAY
Reynolds Medical , Ltd.
MWJ

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