Electrocardiograph, Ambulatory (Without Analysis)

FDA product code MWJ · 62 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.2800
Review panel: CV
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1998-11-10 – 2026-09-11

MWJ 2026-09-11

Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)

Applicant Shenzhen Xinyan Medical Technology Co.,ltd.

K number K254119

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MWJ 2026-09-04

Peerbridge COR MDx (Cor MDx)

Applicant Peerbridge Health, Inc.

K number K253529

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MWJ 2026-08-14

medilogFD

Applicant Schiller AG

K number K253562

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MWJ 2026-06-25

mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)

Applicant Seers Technology Co., Ltd.

K number K253384

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MWJ 2026-06-18

ZywieZ3 Sensor & Adhesive

Applicant Zywie, Inc.

K number K252839

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MWJ 2024-12-13

HeartBeam AIMIGo(TM) System

Applicant Heartbeam, Inc.

K number K231424

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MWJ 2024-05-07

ASSURE Wearable ECG

Applicant Kestra Medical Technologies, Inc.

K number K233864

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MWJ 2022-11-07

Eclipse MINI Model 98900

Applicant Spacelabs Healthcare, Ltd.

K number K212317

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MWJ 2022-07-28

Biotres

Applicant Biotricity

K number K222017

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MWJ 2022-06-02

Q Patch

Applicant Medicalgorithmics S.A.

K number K210758

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MWJ 2022-01-19

Biotres

Applicant Biotricity

K number K211709

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MWJ 2021-11-22

Eclipse PRO

Applicant Spacelabs Healthcare, Ltd.

K number K211651

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MWJ 2018-06-08

Integrated CardioRespiratory System

Applicant Sensydia, Inc.

K number K173156

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MWJ 2016-06-13

NR Recorder

Applicant Norav Medical GmbH

K number K161062

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MWJ 2016-02-26

H3+ Holter Recorder

Applicant Mortara Instrument, Inc.

K number K152626

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MWJ 2013-10-16

BRAEMAR CARDIOKEY HOLTER RECORDER

Applicant Braemar Manufacturing, LLC

K number K130294

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MWJ 2013-07-26

SEER 1000

Applicant Getemed Medizin- Und Informationstechnik AG

K number K130785

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MWJ 2013-03-28

CARDIOMEM

Applicant Getemed Medizin- Und Informationstechnik AG

K number K122272

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MWJ 2012-03-22

EZSLEEP SLEEP QUALITY RECORDER

Applicant Platinum Team Co., Ltd.

K number K112573

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MWJ 2011-11-09

INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER

Applicant Intricon Datrix Corporation

K number K112601

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MWJ 2011-02-04

MH1 MICROHOLTER RECORDER

Applicant Exelys, LLC

K number K101969

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MWJ 2011-01-06

KENZ CARDY302 MAX

Applicant Suzuken Co., Ltd.

K number K101024

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MWJ 2010-12-09

MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS

Applicant Memtec Corp.

K number K102723

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MWJ 2010-10-13

BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS

Applicant BTL Industries, Inc.

K number K100310

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MWJ 2010-04-29

ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603

Applicant Camntech, Ltd.

K number K100266

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MWJ 2009-08-13

CHROMA, MODEL: RZ153C

Applicant Scottcare Corporation

K number K083382

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MWJ 2009-07-27

WALK400H

Applicant Et Medical Devices Spa

K number K091054

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MWJ 2008-09-09

AUDICOR, HEMO AMBULATORY MONITOR

Applicant Inovise Medical, Inc.

K number K073545

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MWJ 2007-10-03

E3-80 PORTABLE ECG RECORDER & ANALYZER

Applicant Micro-Star International Co., Ltd.

K number K071085

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MWJ 2007-07-24

DL900 SERIES HOLTER RECORDER

Applicant Braemar, Inc.

K number K071733

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MWJ 2007-05-30

CARDIOMEM CM 3000-12BT

Applicant Getemed Medizin- Und Informationstechnik AG

K number K063042

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MWJ 2007-05-25

AUTO DETECT FOR TELAHEART DR200/E-A

Applicant North East Monitoring, Inc.

K number K070014

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MWJ 2007-04-27

MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER

Applicant Braemar, Inc.

K number K071011

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MWJ 2006-10-16

DMS 300-2, 300-3 AND 300-4

Applicant Diagnostic Monitoring Software

K number K062959

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MWJ 2006-08-25

TELAHEART DIGITAL RECORDER

Applicant North East Monitoring, Inc.

K number K061293

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MWJ 2005-07-14

CARDIOMEM CM 3000-12

Applicant Getemed Medizin- Und Informationstechnik AG

K number K051686

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MWJ 2005-05-19

SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM

Applicant Ge Medical Systems Information Technologies

K number K050731

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MWJ 2005-02-25

HOLTER RECORDER H3+

Applicant Mortara Instrument, Inc.

K number K043010

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MWJ 2004-10-06

BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER

Applicant Braemar, Inc.

K number K042469

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MWJ 2004-08-31

SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER

Applicant North East Monitoring, Inc.

K number K041901

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MWJ 2004-01-28

RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100

Applicant Recom Managed Systems, Inc.

K number K032882

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MWJ 2003-10-15

DIGITAL AMBULATORY ECG (HOLTER) RECORDER

Applicant Datrix

K number K031074

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MWJ 2003-08-27

CLICK HOLTER

Applicant Remco Italia S.P.A.

K number K032276

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MWJ 2003-08-22

SPIDERVIEW

Applicant Ela Medical, Inc.

K number K032466

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MWJ 2003-03-28

ER800 SERIES ECG EVENT RECORDER

Applicant Braemar Corp.

K number K030856

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MWJ 2002-11-14

SEER LIGHT COMPACT DIGITAL HOLTER RECORDER

Applicant General Electric Medical Systems Information Techn

K number K021470

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MWJ 2002-06-27

H12+HOLTER RECORDER

Applicant Mortara Instrument, Inc.

K number K021373

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MWJ 2001-07-13

LIFECARD CF 7 DAY

Applicant Reynolds Medical , Ltd.

K number K011837

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MWJ 2001-05-16

CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A

Applicant Cardionet

K number K003707

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MWJ 2000-12-13

NEXAN SYSTEM, MODEL NX-300

Applicant Nexan, Ltd.

K number K003520

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MWJ 2000-07-27

CARDIOVISE ECG INTERPRETATIVE SOFTWARE

Applicant Inovise Medical, Inc.

K number K001349

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MWJ 2000-07-21

ARIA

Applicant Del Mar Medical Systems, LLC

K number K001317

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MWJ 2000-07-20

DR180-II

Applicant North East Monitoring, Inc.

K number K001288

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MWJ 2000-05-23

CARDTEL, MODEL NT-100

Applicant Cardiac Telecommunications

K number K000609

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MWJ 2000-01-13

PE 501 PC-ECG MONITOR

Applicant Nhe Corp.

K number K992584

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MWJ 1999-12-28

NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100

Applicant Nexan Telemed , Ltd.

K number K993643

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MWJ 1999-11-24

DXP1000 HOLTER RECORDER

Applicant Braemar Corp.

K number K993618

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MWJ 1999-11-24

DIGITRAKPLUS HOLTER RECORDER

Applicant Braemar Corp.

K number K993617

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MWJ 1999-10-19

TES-20

Applicant Tes Electrical Electronic Corp.

K number K992425

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MWJ 1999-04-09

TRACER

Applicant Heartland Medical Systems, Inc.

K number K982617

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MWJ 1998-11-10

DIGITAL ECG HOLTER RECORDER, MODEL DR512

Applicant Datrix

K number K982975

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MWJ 1998-11-10

CMS-2000

Applicant Industrial Technology Research Institute

K number K982843

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