Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Electrocardiograph

FDA product code DPS · 558 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.2340
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-19 – 2026-09-25

DPS 2012-04-03

PAGEWRITER TC 20, 30, 50, 70

Applicant Philips Medical Systems

K number K113144

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DPS 2012-03-16

ELECTROCARDIOGRAPH

Applicant Edan Instruments, Inc.

K number K120188

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DPS 2012-01-26

CALG-STR EXERCISE ECG ANALYSIS ALGORITHM

Applicant Philips Health Care

K number K112959

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DPS 2011-12-22

HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME

Applicant Cardiocomm Solutions, Inc.

K number K111159

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DPS 2011-11-17

MOBCARDIO SYSTEM

Applicant Mobhealth Incorporation

K number K113234

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DPS 2011-11-02

VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI

Applicant Vectracor, Inc.

K number K102378

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DPS 2011-10-21

PHYSIOGLOVE ES WITH ECG ANALYSIS

Applicant Commwell , Ltd.

K number K103791

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DPS 2011-09-22

DIGITAL ELECTROCARDIOGRAPH

Applicant Shenzhen Biocare Electronics Co., Ltd.

K number K112431

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DPS 2011-09-12

REKA E100

Applicant Reka Pte, Ltd.

K number K111438

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DPS 2011-08-24

ECG SERIES ELECTROCARDIOGRAPH

Applicant Advanced Instrumentations, Inc.

K number K111805

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DPS 2011-08-05

ECG-6 SERIES ELECTROCARDIOGRAPH

Applicant Advanced Instrumentations, Inc.

K number K112135

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DPS 2011-07-15

ACG-8511 PORTABLE ECG MONITOR

Applicant Andon Health Co, Ltd.

K number K110328

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DPS 2011-07-13

ECG PEN

Applicant Meridian Dynamics Biomedical, Inc.

K number K103077

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DPS 2011-07-08

HERO

Applicant Medical Predictive Science Corp.

K number K111601

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DPS 2011-06-03

CARDIO XP

Applicant Bionet Co., Ltd.

K number K102767

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DPS 2011-05-17

MAC 600 RESTING ECG ANALYSIS SYSTEM

Applicant Ge Medical Systems Information Technologies, Inc.

K number K103765

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DPS 2011-04-29

MAC 5500 HD, MAC 3500

Applicant Ge Medical Systems Information Technologies, Inc.

K number K110266

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DPS 2011-04-14

VICOR PD2I ANALYZER

Applicant Vicor Technologies, Inc.

K number K101867

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DPS 2011-03-24

MOBILEECG SYSTEM

Applicant Memtec Corp.

K number K103427

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DPS 2011-03-22

MIDMARK IQECG

Applicant Brentwood Medical Technology Corp.

K number K103640

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DPS 2011-03-02

SPAULDING IQ ELECTROCARDIOGRAPH

Applicant Spaulding Clinical Research, LLC

K number K110065

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DPS 2011-03-01

DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010

Applicant Shenzhen Biocare Electronics Co., Ltd.

K number K101876

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DPS 2011-03-01

V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER

Applicant Taidoc Technology Corporation

K number K101569

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DPS 2011-02-18

ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10

Applicant Mortara Instrument, Inc.

K number K102206

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DPS 2011-01-28

ANS SYSTEM

Applicant Caird Technology

K number K101016

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DPS 2010-12-03

PC ECG

Applicant Edan Instruments, Inc.

K number K102854

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DPS 2010-12-02

ELECTROCARDIOGRAPH

Applicant Edan Instruments, Inc.

K number K102830

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DPS 2010-07-23

QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB

Applicant Pulse Biomedical, Inc.

K number K100813

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DPS 2010-07-02

ELI 250 ELECTROCARDIOGRAPH

Applicant Mortara Instrument, Inc.

K number K101403

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DPS 2010-06-18

ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150

Applicant Mortara Instrument, Inc.

K number K101115

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DPS 2010-06-03

CARECENTER MD

Applicant Cardiac Science Corporation

K number K093211

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DPS 2010-04-16

ELI 230 ELECTROCARDIOGRAPH

Applicant Mortara Instrument, Inc.

K number K100127

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DPS 2010-04-01

SE-601 SERIES ELECTROCARDIOGRAPH

Applicant Edan Instruments, Inc.

K number K093869

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DPS 2010-03-31

HANDHELD ECG MONITOR, MODEL MD100

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K number K093872

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DPS 2010-02-19

ELI PC ELECTROCARDIOGRAPH

Applicant Mortara Instrument, Inc.

K number K093339

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DPS 2010-01-20

QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)

Applicant Dynacardia, Inc.

K number K093172

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DPS 2009-12-14

ELI 350 ELECTROCARDIOGRAPH

Applicant Mortara Instrument, Inc.

K number K092663

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DPS 2009-10-22

PC ECG, MODEL SE-1010

Applicant Edan Instruments, Inc.

K number K092010

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DPS 2009-09-15

BELTBEAT WF-400

Applicant Bonus Communicaciones Srl

K number K083715

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DPS 2009-09-04

GEM HEART ONE/ONE+

Applicant Gem-Med S.L.

K number K092576

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DPS 2009-08-25

SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A

Applicant Contec Medical System Co., Ltd.

K number K090936

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DPS 2009-07-24

SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200

Applicant Edan Instruments, Inc.

K number K091513

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DPS 2009-07-08

ECSCOPE 200

Applicant Dyansys, Inc.

K number K091397

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DPS 2009-06-03

SE-601 SERIES ELECTROCARDIOGRAPH

Applicant Edan Instruments, Inc.

K number K090367

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DPS 2009-05-28

ECSCOPE 100

Applicant Dyansys, Inc.

K number K091358

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DPS 2009-04-03

MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM

Applicant Harbinger Medical, Inc.

K number K090249

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DPS 2009-03-26

MORTARA STRESS ECHO BED

Applicant Medical Positioning, Inc.

K number K082967

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DPS 2009-03-20

SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS

Applicant Philips Medical Systems

K number K090483

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DPS 2009-02-19

MAC 800 RESTING ECG ANALYSIS SYSTEM

Applicant Ge Medical Syst. Information Technologies

K number K090212

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DPS 2009-02-19

CARDITTE MICROTEL

Applicant Et Medical Devices Spa

K number K082124

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DPS 2008-12-29

MORTARA ELI 350 ELECTROCARDIOGRAPH

Applicant Mortara Instrument, Inc.

K number K082946

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DPS 2008-12-29

VICOR PD2I ANALYZER, VERSION 2.1

Applicant Vicor Technologies, Inc.

K number K082709

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DPS 2008-12-03

VICARDIO 12B

Applicant Energy-Lab Technologies GmbH

K number K082380

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DPS 2008-11-10

CLUE MEDICAL AND CLUE MEDICAL BASIC

Applicant Telovital GmbH Telemedizin

K number K082013

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DPS 2008-09-26

HANDHELD ECG MONITOR, MODEL MD100

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K number K080933

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DPS 2008-09-12

PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)

Applicant Heartscape Technologies, Ltd.

K number K082312

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DPS 2008-08-26

Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S

Applicant Cardiac Science Corporation

K number K082173

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DPS 2008-07-15

MAC 1600 ECG ANALYSIS SYSTEM

Applicant Ge Medical Systems Information Technologies

K number K081437

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DPS 2008-06-27

HERO, VERSION 2.0

Applicant Medical Predictive Science Corp.

K number K081473

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DPS 2008-05-09

PAGEWRITER CARDIOGRAPH

Applicant Philips Medical Systems

K number K080999

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DPS 2008-04-11

QHRV 1 - HEALTH ASSESSMENT SYSTEM

Applicant Medtechs, LLC

K number K080884

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DPS 2008-01-25

MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM

Applicant Ge Healthcare Systems Information Technologies

K number K073625

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DPS 2008-01-16

PORTABLE ECSCOPE 12I

Applicant Dyansys, Inc.

K number K080036

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DPS 2007-11-29

CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS

Applicant Welch Allyn, Inc.

K number K072449

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DPS 2007-08-31

THE PORTABLE ANSISCOPE

Applicant Dyansys, Inc.

K number K071168

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DPS 2007-08-30

PORTABLE ECSCOPE

Applicant Dyansys Corp

K number K072353

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DPS 2007-08-30

ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M

Applicant Nihon Kohden America, Inc.

K number K072217

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DPS 2007-08-17

QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V

Applicant Nihon Kohden America, Inc.

K number K072060

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DPS 2007-06-29

PALM ECG RECORDER, MODEL EP-201/202

Applicant Parama-Tech Company., Ltd.

K number K061123

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DPS 2007-05-04

CORSCREEN

Applicant Viasys Healthcare GmbH

K number K070614

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DPS 2007-04-13

AUDICOR 200 SYSTEM, MODELS 200D AND 200S

Applicant Inovise Medical, Inc.

K number K070136

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DPS 2007-03-22

MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0

Applicant Monebo Technologies, Inc.

K number K062282

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DPS 2007-03-15

MORTARA ELI 10 ELECTROCARDIOGRAPH

Applicant Mortara Instrument, Inc.

K number K070539

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DPS 2007-02-08

INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0

Applicant Dailycare Biomedical, Inc.

K number K062894

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DPS 2006-11-15

ELI 350 ELECTROCARDIOGRAPH

Applicant Mortara Instrument, Inc.

K number K062677

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DPS 2006-11-03

VOYAGER 12

Applicant Del Mar Reynolds Medical, Ltd.

K number K062469

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DPS 2006-10-27

INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0

Applicant Intelwave, LLC

K number K062068

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DPS 2006-06-09

PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801

Applicant Omron Healthcare, Inc.

K number K060766

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DPS 2006-05-24

CARDIOFAX CE, MODEL ECG-1500 A

Applicant Nihon Kohden America, Inc.

K number K052511

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DPS 2006-04-25

PHYSIOGLOVE ES

Applicant Commwell , Ltd.

K number K050674

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DPS 2006-04-19

ATRIA 3100, ATRIA 6100

Applicant Cardiac Science Corporation

K number K060167

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DPS 2006-03-28

IQMARK EZ STRESS

Applicant Brentwood Medical Technology Corp.

K number K052898

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DPS 2006-01-31

GALIX ECG PROFESSIONAL STATION

Applicant Galix Biomedical Instrumentation, Inc.

K number K051163

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DPS 2006-01-13

CARDIOSOFT PC ECG, USB VERSION

Applicant Cardiosoft, L.P.

K number K052295

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DPS 2005-12-16

READMYHEART, MODEL RMH2.0

Applicant Dailycare Biomedical, Inc.

K number K052303

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DPS 2005-11-30

DATRIX CARDIO WIFI ELECTROCARDIOGRAPH

Applicant Datrix

K number K053083

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DPS 2005-10-05

CARDIOLINE AR 600, AR 1200, AR 2100

Applicant Et Medical Devices Spa

K number K051534

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DPS 2005-08-26

PHILIPS 12-LEAD ALGORITHM

Applicant Philips Medical Systems

K number K052049

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DPS 2005-07-14

READMYHEART, MODEL RMH3.0

Applicant Dailycare Biomedical, Inc.

K number K050620

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DPS 2005-06-29

ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM

Applicant Heartlab, Inc.

K number K050858

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DPS 2005-05-19

CARDIOSCOPE SONOPLUS 3000

Applicant Pulsonic Ag, Medical Technology

K number K051126

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DPS 2005-05-04

CARDIOVIT AT-10PLUS

Applicant Schiller AG

K number K050686

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DPS 2005-04-26

MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1

Applicant Monebo Technologies, Inc.

K number K043380

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DPS 2005-03-22

12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200

Applicant Welch Allyn, Inc.

K number K050074

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DPS 2005-02-22

LIBERTY SYSTEM

Applicant Inovise Medical, Inc.

K number K043074

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DPS 2005-01-06

CARDIOFAX CE, MODEL PEA-1110K

Applicant Nihon Kohden America, Inc.

K number K042827

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DPS 2005-01-06

READMYHEART

Applicant Dailycare Biomedical, Inc.

K number K042814

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DPS 2004-08-27

MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM

Applicant Ge Medical Systems Information Technologies

K number K042177

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DPS 2004-07-07

CMI MAGNETOCARDIOGRAPH

Applicant Cmi Cardiomag Imaging, Inc.

K number K033488

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DPS 2004-04-14

CARDIOVIT AT-102

Applicant Schiller AG

K number K031557

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