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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 2026-09-25

S-Patch CardioAI

Applicant Wellysis Corp.

K number K254255

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DPS 2026-07-02

SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)

Applicant Edan Instruments, Inc.

K number K252463

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DPS 2026-01-26

MAC 7 Resting ECG Analysis System

Applicant Ge Medical Systems Information Technologies, Inc.

K number K251670

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DPS 2025-12-22

AccurECG Analysis System (v2.0)

Applicant Accurkardia, Inc.

K number K252361

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DPS 2025-11-10

Withings BeamO (SCT02)

Applicant Withings

K number K252474

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DPS 2025-08-06

Cardiologs Holter Platform

Applicant Philips France Commercial

K number K250569

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DPS 2025-07-10

ZBPro Diagnostic

Applicant Zbeats, Inc.

K number K243252

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DPS 2025-04-03

Masimo W1

Applicant Masimo Corporation

K number K243305

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DPS 2025-01-16

CloudHRV™ System (100-01-001)

Applicant Inmedix, Inc.

K number K241217

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DPS 2024-12-17

Cardiac Workstation (5000); Cardiac Workstation (7000)

Applicant Philips Medizin Systeme Böblingen GmbH

K number K241556

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DPS 2024-08-08

Masimo W1

Applicant Masimo Corporation

K number K240229

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DPS 2024-06-20

DeepRhythm Platform

Applicant Medicalgorithmics S.A.

K number K232161

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DPS 2024-06-12

MEDIBLU ECG SYSTEM

Applicant Mediblu Medical, LLC

K number K233266

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DPS 2024-06-07

Electrocardiograph, model: ECG301

Applicant Shenzhen LE Medical Technology Co., Ltd.

K number K232816

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DPS 2024-06-07

Impala

Applicant AliveCor, Inc.

K number K232035

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DPS 2024-05-02

CSF-4 (CSF-4)

Applicant Cardiacsense

K number K232445

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DPS 2024-04-05

MCG-S (AM1000)

Applicant Amcg Co., Ltd.

K number K232823

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DPS 2023-12-15

Cardio Q50, Cardio Q70

Applicant Bionet Co., Ltd.

K number K231160

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DPS 2023-11-21

CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H

Applicant Trismed Co., Ltd.

K number K230834

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DPS 2023-11-17

EKGenius Smart System

Applicant Ekgenius, LLC

K number K232974

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DPS 2023-11-17

Masimo W1

Applicant Masimo Corporation

K number K232512

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DPS 2023-11-09

Cardio P1

Applicant Bionet Co., Ltd.

K number K231150

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DPS 2023-08-23

Withings Scan Monitor 2.0

Applicant Withings

K number K230812

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DPS 2023-07-28

MESI mTablet ECG Diagnostic System, MESI mTablet ECG

Applicant Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.

K number K223670

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DPS 2023-07-28

Electrocardiograph: SE-1200 Pro and SE-1201 Pro

Applicant Edan Instruments, Inc.

K number K222902

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DPS 2023-06-23

AccurECG Analysis System

Applicant Accurkardia, Inc.

K number K223013

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DPS 2023-01-06

CSF-3

Applicant Cardiacsense

K number K221260

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DPS 2022-12-02

PageWriter TC35 Cardiograph

Applicant Medizin Systeme Boblingen GmbH

K number K221141

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DPS 2022-11-15

Cardio10

Applicant Bionet Co., Ltd.

K number K220535

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DPS 2022-10-18

MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System

Applicant Ge Medical Systems Information Technologies, Inc.

K number K221321

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DPS 2022-04-14

Coala Heart Monitor

Applicant Coala Life AB

K number K212163

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DPS 2022-04-07

Electrocardiograph

Applicant Edan Instruments, Inc.

K number K212278

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DPS 2022-03-25

LE-12CH

Applicant Caf Medical Solutions, Inc.

K number K220362

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DPS 2021-11-18

Cardiologs Holter Platform

Applicant Cardiologs Technologies

K number K212112

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DPS 2021-10-05

Scan Monitor

Applicant Withings SA

K number K201456

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DPS 2021-10-01

electrocardiograph: SE-1202

Applicant Edan Instruments, Inc.

K number K210140

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DPS 2021-06-30

Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph

Applicant Philips Medical Systems

K number K210560

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DPS 2021-04-30

MAC 7 - Resting ECG Analysis System

Applicant Ge Medical Systems Information Technologies, Inc.

K number K203786

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DPS 2020-12-07

B-Secur HeartKey Software Library

Applicant B-Secur , Ltd.

K number K200884

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DPS 2020-09-29

PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph

Applicant Philips Medical Systems

K number K191738

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DPS 2020-06-11

physIQ Heart Rhythm and Respiration Module

Applicant Physiq, Inc.

K number K193415

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DPS 2020-03-20

AI-ECG Tracker

Applicant Shenzhen Carewell Electronics Co., Ltd.

K number K200036

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DPS 2020-03-02

CARDIOVIT AT-102 G2

Applicant Schiller AG

K number K183425

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DPS 2020-01-10

KardioScreen

Applicant Imedrix Inc. (Formerly Piitech Inc.)

K number K191692

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DPS 2019-07-10

physIQ Heart Rhythm and Respiratory Module

Applicant Physiq, Inc.

K number K183322

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DPS 2019-03-15

CardioFlux with Faraday Analytical Cloud

Applicant Genetesis, Inc.

K number K182571

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DPS 2019-01-28

ZOLL ECG Analysis Software

Applicant Zoll Manufacturing Corporation

K number K182093

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DPS 2018-12-28

COR12 ECG

Applicant Corscience GmbH & Co.

K number K183369

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DPS 2018-12-14

Cardio-TriTest v6.5

Applicant Cardio-Phoenix, Inc.

K number K182790

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DPS 2018-11-15

CardioBand ECG Event Recorder

Applicant Samsung Strategy and Innovation Center (Ssic)

K number K181998

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DPS 2018-09-18

MAC VU360 Resting ECG Analysis System

Applicant Ge Medical Systems Information Technologies, Inc.

K number K173830

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DPS 2018-08-28

Universal SmartECG

Applicant Vectracor, Inc.

K number K173952

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DPS 2018-08-10

physiQ Heart Rhythm Module

Applicant Physiq, Inc.

K number K180234

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DPS 2018-07-05

CheckMyHeart Plus

Applicant Dailycare Biomedical, Inc.

K number K172778

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DPS 2018-06-01

Kenz Cardico1211

Applicant Suzuken Co., Ltd.

K number K172068

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DPS 2018-04-16

CardiMax Electrocardiograph

Applicant Fukuda Denshi USA, Inc.

K number K173226

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DPS 2018-02-28

HeRO Symphony, HeRO ES, HeRO solo/duet

Applicant Medical Predictive Science Corporation

K number K180242

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DPS 2018-01-26

MiCor A100 Wearable ECG Recorder

Applicant Mitac International Corp.

K number K162665

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DPS 2018-01-24

Electrocardiograph

Applicant Edan Instruments, Inc.

K number K171942

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DPS 2018-01-22

CONTEC™ Electrocardiograph

Applicant Contec Medical Systems Co.,Ltd

K number K171360

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DPS 2018-01-11

Digital Electrocardiograph

Applicant Biocare Bio-Medical Equipment Co., Ltd.

K number K171517

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DPS 2017-12-15

ECG Acquisition Systems

Applicant Vales & Hills Biomedical Tech. , Ltd.

K number K163607

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DPS 2017-10-12

Creavo Vitalscan Magnetocardiograph

Applicant Creavo Medical Technologies, Ltd.

K number K170154

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DPS 2017-09-25

Electrocardiograph

Applicant Edan Instruments, Inc.

K number K171943

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DPS 2017-07-19

CARDIOVIT FT-1

Applicant Schiller AG

K number K170182

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DPS 2017-06-26

CardioLogs ECG Analysis Platform

Applicant Cardiologs Technologies

K number K170568

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DPS 2017-06-02

Electrocardiograph

Applicant Edan Instruments, Inc.

K number K170995

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DPS 2017-05-30

Portable ECG Monitor

Applicant Contec Medical Systems Co.,Ltd

K number K170954

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DPS 2017-05-11

Anybattery C2 Rechargeable Battery

Applicant Anybattery, Inc.

K number K160667

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DPS 2017-02-15

PC ECG

Applicant Edan Instruments, Inc.

K number K160876

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DPS 2016-11-02

CARDIOLINE touchECG

Applicant Cardioline S.P.A

K number K160746

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DPS 2016-08-12

ECG100+, ECG200+

Applicant Cardioline S.P.A

K number K160840

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DPS 2016-08-09

Quantitative Electrocardiographic Detector (QED 2000)

Applicant Acme Portable Machines, Inc.

K number K152135

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DPS 2016-07-01

PC ECG

Applicant Edan Instruments, Inc.

K number K161302

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DPS 2016-06-22

Portable ECG Monitor

Applicant Contec Medical Systems Co.,Ltd

K number K152863

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DPS 2016-05-06

Diagnostic Station DS20

Applicant Schiller AG

K number K152043

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DPS 2016-03-15

MODEL 621/624 BIOMAGNETOMETER

Applicant Tristan Technologies, Inc.

K number K151135

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DPS 2016-02-23

ANI Monitor

Applicant Mdoloris Medical Systems Sas

K number K142969

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DPS 2016-02-12

Digital Electrocardiograph

Applicant Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

K number K160092

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DPS 2016-02-05

PC ECG

Applicant Edan Instruments, Inc.

K number K152427

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DPS 2016-01-06

Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems

Applicant Mortara Instrument, Inc.

K number K152944

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DPS 2013-11-22

PC ECG

Applicant Edan Instruments, Inc.

K number K131819

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DPS 2013-11-14

DIGITAL ELECTROCARDIOGRAPHS

Applicant Sonoscape Company Limited

K number K131262

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DPS 2013-09-26

PHILIPS DXL 12/16-LEAD ECG ALGORITHM

Applicant Philips Medical Systems

K number K132068

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DPS 2013-09-06

ALIVECOR HEART MONITOR

Applicant AliveCor, Inc.

K number K130409

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DPS 2013-07-23

SPACELABS HEALTHCARE CARDIOEXPRESS

Applicant Spacelabs Healthcare, Ltd.

K number K130207

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DPS 2013-07-22

MICRO AMBULATORY ECG RECORDER

Applicant Dimetek Digital Medical Technologies, Ltd.

K number K131572

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DPS 2013-07-03

CP150 ELECTROCARDIOGRAPH

Applicant Welch Allyn, Inc.

K number K131573

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DPS 2013-03-11

CS-MAG II

Applicant Biomagnetik-Park GmbH

K number K121825

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DPS 2013-02-27

DIGITAL ELECTROCARDIOGRAPHS

Applicant Shenzhen Biocare Electronics Co., Ltd.

K number K123816

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DPS 2013-02-05

CARDEASCREEN

Applicant Cardea Associates, Inc.

K number K123217

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DPS 2012-12-06

QT GUARD PLUS ANALYSIS SYSTEM

Applicant Ge Medical Systems Information Technologies

K number K120770

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DPS 2012-11-19

ALIVECOR HEART MONITOR FOR IPHONE

Applicant AliveCor, Inc.

K number K122356

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DPS 2012-10-25

DIGITAL ELECTROCARDIOGRAPH

Applicant Shenzhen Biocare Electronics Co., Ltd.

K number K122712

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DPS 2012-08-02

ELI 280 ELECTROCARDIOGRAPH

Applicant Mortara Instrument, Inc.

K number K122073

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DPS 2012-07-19

RSCRIBE ELECTROCARDIOGRAPH

Applicant Mortara Instrument, Inc.

K number K120865

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DPS 2012-07-19

HANDHELD ECG MONITOR

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K number K112622

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DPS 2012-07-16

CARDIO 7

Applicant Bionet Co., Ltd.

K number K113306

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DPS 2012-05-17

HEARTCHECK ECG PEN WITH GEMS HOME

Applicant Cardiocomm Solutions, Inc.

K number K121009

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DPS 2012-04-25

ELECTROCARDIOGRAPH

Applicant Shenzhen Carewell Electronics Co., Ltd.

K number K113485

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