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 1993-07-29

CARDIAX

Applicant Fairlake Marketing Group, Inc.

K number K924544

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DPS 1993-05-07

SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFI

Applicant Siemens Medical Electronics

K number K921930

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DPS 1993-04-27

MORTARA INSTRUMENT, INC. E-SCRIBE

Applicant Mortara Instrument, Inc.

K number K930558

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DPS 1993-04-27

THE ACTA FORMULA

Applicant Biosound, Inc.

K number K922703

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DPS 1993-04-09

9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT

Applicant S & W Medico Teknik

K number K930134

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DPS 1993-03-08

KING OF HEARTS SCEPTER

Applicant Instromedix, Inc.

K number K923221

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DPS 1992-11-10

MORTARA INSTRUMENT ST CENTRAL STATION

Applicant Mortara Instrument, Inc.

K number K922927

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DPS 1992-11-04

PERSONAL 120/210 LAPTOP STRESS OPTION

Applicant Biosound, Inc.

K number K922291

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DPS 1992-07-09

CARDIO-CARD ECG MANAGEMENT SYSTEM

Applicant Nasiff Assoc., Inc.

K number K920020

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DPS 1992-06-23

TYPE 9050/NEO

Applicant S & W Medico Teknik

K number K912183

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DPS 1992-05-11

CAMBRIDGE PC/GXT STRESS TEST SYSTEM

Applicant Health Watch, Inc.

K number K921331

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DPS 1992-03-30

ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST

Applicant Kardiosis Ltd. Co.

K number K914206

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DPS 1992-03-17

ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS

Applicant Biosound, Inc.

K number K920364

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DPS 1992-02-14

MODIFIED PREDICTOR IIC SIGNAL AVERAGING ECG

Applicant Corazonic Corp.

K number K915760

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DPS 1992-01-27

HL-300 RECEIVER MODULE

Applicant Fukuda Denshi USA, Inc.

K number K915879

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DPS 1992-01-23

CARDIO PERFECT, CARDIO PERFECT MD

Applicant Cardio Control BV

K number K913374

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DPS 1991-12-19

MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST

Applicant Medtronic Vascular

K number K914974

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DPS 1991-12-05

MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR

Applicant Micromed

K number K914762

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DPS 1991-11-05

COORDINATOR, CABLE INPUT

Applicant Cardiotronics, Inc.

K number K914725

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DPS 1991-11-05

Q4500 STREE TEST MONITOR

Applicant Quinton, Inc.

K number K910017

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DPS 1991-08-29

LP-PLUS

Applicant Fidelity Medical, Inc.

K number K903774

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DPS 1991-05-23

CARDIOCAP II TM CH-RESP MONITORS

Applicant Instrumentarium Corp.

K number K904355

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DPS 1991-03-01

MODEL 405

Applicant Ivy Biomedical Systems, Inc.

K number K904606

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DPS 1991-03-01

HORIZON 2000 ST ANALYSIS OPTION

Applicant Mennen Medical, Inc.

K number K903524

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DPS 1991-01-03

ATHANS EKG STANDARDIZER

Applicant Advanced Medical Concepts, Inc.

K number K903671

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DPS 1990-12-13

CARDIOFAX ECG-8830A

Applicant Nihon Kohden America, Inc.

K number K904758

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DPS 1990-12-05

MICROMED QRS CARD

Applicant Nasiff Assoc., Inc.

K number K903722

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DPS 1990-09-11

PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH

Applicant Esaote Biomedica Spa

K number K902368

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DPS 1990-08-23

FUKUDA DENSHI MODEL FX-3101

Applicant Fukuda Denshi USA, Inc.

K number K901817

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DPS 1990-07-17

CARDISUNY 501BIII

Applicant Graham-Field, Inc.

K number K901948

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DPS 1990-07-17

CARDISUNY 501AB

Applicant Graham-Field, Inc.

K number K901947

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DPS 1990-05-30

SIEMENS SIRECUST 732, PATIENT MONITOR

Applicant Siemens Medical Electronics

K number K901771

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DPS 1990-04-30

QEKG ELECTROCARDIOGRAPH

Applicant Qmed, Inc.

K number K897121

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DPS 1990-04-26

TRAMSCOPE SYSTEM

Applicant Marquette Electronics, Inc.

K number K900598

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DPS 1990-04-26

MODEL ECG100 SIMULATOR

Applicant Dynatech/Nevada, Inc.

K number K897029

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DPS 1990-04-04

PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA

Applicant Accucore, Inc.

K number K901032

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DPS 1990-04-03

SMU 611 UNIVERSALMONITOR

Applicant Ppg Industries, Inc.

K number K900700

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DPS 1990-03-08

CARDIOCAP(TM) CMX-104 MONITOR

Applicant Datex Division Instrumentarium Corp.

K number K896190

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DPS 1990-02-26

EKG, ECG KENZ, ECG 303

Applicant Cambridge Medical Instruments, Inc.

K number K896772

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DPS 1990-02-05

CIRCAMED HOLTER VERSION 4

Applicant Circadian, Inc.

K number K894956

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DPS 1990-01-31

NKA MODELS AB-601G AND AB-621G

Applicant Nihon Kohden America, Inc.

K number K900272

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DPS 1990-01-26

AMBULATORY CARDIAC MONITOR

Applicant Monitech, Inc.

K number K896064

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DPS 1989-12-13

MINIMON 7133B PATIENT MONITOR

Applicant Kontron Instruments, Inc.

K number K896386

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DPS 1989-12-12

KONTRON KOLORMON 7250 PATIENT MONITOR

Applicant Kontron Instruments, Inc.

K number K896417

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DPS 1989-12-05

ECG SIMULATOR MODEL ECGPLUS

Applicant Bio-Tek Instruments, Inc.

K number K893660

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DPS 1989-10-17

CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512

Applicant Ppg Industries, Inc.

K number K890875

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DPS 1989-06-22

ACTA GENOS ELECTROCARDIOGRAPH

Applicant Parexel Intl. Corp.

K number K884800

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DPS 1989-06-01

E350 ELECTROCARDIOGRAPH

Applicant Burdick Corp.

K number K892835

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DPS 1989-05-02

SIEMENS SIRECUST 730 PATIENT MONITOR

Applicant Siemens Medical Electronics

K number K890791

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DPS 1989-04-26

TYPE 9040 SYSTEM ATHENA

Applicant S & W Medico Teknik

K number K884116

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DPS 1989-03-31

7610 COLORVIEW SLAVE SCOPE

Applicant Marquette Electronics, Inc.

K number K890481

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DPS 1989-03-31

PHYSIOGARD SM 785

Applicant Adam

K number K885177

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DPS 1989-03-09

ELECTRODE GEL

Applicant Herbert Stanley Co.

K number K884504

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DPS 1989-03-09

NR2000 CARDIAC MONITOR

Applicant Nirad , Ltd.

K number K883903

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DPS 1989-02-23

BP-308 MARK II

Applicant Colin Medical Instruments Corp.

K number K884896

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DPS 1989-02-02

PATIENT MONITOR MODEL 703

Applicant Ivy Biomedical Systems, Inc.

K number K884662

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DPS 1989-01-25

MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH

Applicant Cambridge Medical Instruments, Inc.

K number K883454

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DPS 1989-01-17

EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)

Applicant Quinton, Inc.

K number K883402

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DPS 1989-01-12

FUKUDA DENSHI MODEL FX-1201

Applicant Fukuda Denshi USA, Inc.

K number K884992

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DPS 1988-12-27

CARDIOCAP(TM) CTO-104 MONITOR

Applicant Datex Division Instrumentarium Corp.

K number K884956

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DPS 1988-12-27

Q5000 ST/HR SLOPE MODIFICATION

Applicant Quinton, Inc.

K number K883468

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DPS 1988-12-05

SYSTEM VI MONITOR

Applicant Air-Shields, Inc.

K number K874326

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DPS 1988-11-17

LOGIC 3 ELECTROCARDIOGRAPH

Applicant Cel-Med Co., Inc.

K number K882472

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DPS 1988-11-09

OEC-7102 ECG/NIBP MONITOR

Applicant Nihon Kohden America, Inc.

K number K882254

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DPS 1988-08-19

ECG MONITOR AND RESPIRATION PACER

Applicant D. E. Hokanson, Inc.

K number K881055

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DPS 1988-08-12

MINIMON 7131B PATIENT MONITOR

Applicant Kontron Instruments, Inc.

K number K882197

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DPS 1988-08-02

SYSTEM5RH STATIONARY EXERCISE BICYCLE

Applicant Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc.

K number K881475

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DPS 1988-08-02

OMNIGRAPH 6000

Applicant Telemed Div.

K number K880357

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DPS 1988-07-28

MINIMON 7132B PATIENT MONITOR

Applicant Kontron Instruments, Inc.

K number K882198

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DPS 1988-07-18

SIRECUST 1280/1281 & 960/961 PATIENT MONITORS

Applicant Siemens Medical Electronics

K number K881939

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DPS 1988-05-18

MODEL 375 ECG

Applicant Birtcher Corp.

K number K881328

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DPS 1988-05-06

HORIZON 2000/S 266-XXX-XXX

Applicant Mennen Medical, Inc.

K number K880595

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DPS 1988-04-01

CIRCADIAN STRESS TEST II

Applicant Circadian, Inc.

K number K874641

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DPS 1988-03-22

FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR

Applicant Fukuda Denshi USA, Inc.

K number K875057

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DPS 1988-01-06

MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPH

Applicant Del Mar Avionics

K number K872658

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DPS 1987-12-15

FITNESS RECUMBENT ERGOMETER, MODEL FT1400

Applicant Invacare Corp.

K number K872548

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DPS 1987-11-23

MC 6000 MULTI-CHANNEL ELECTROCARDIOGRAPH

Applicant Cambridge Medical Instruments, Inc.

K number K871993

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DPS 1987-10-26

MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR

Applicant Quinton, Inc.

K number K873584

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DPS 1987-10-07

MODEL 2240 SLAVE SCOPE

Applicant Marquette Electronics, Inc.

K number K873346

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DPS 1987-06-16

LP-3 ELECTROCARDIOGRAPH

Applicant Fidelity Medical, Inc.

K number K864614

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DPS 1987-06-05

ACUSON PHYSIOLOGICAL CONTROL MODULE

Applicant Acuson Computed Sonography

K number K871239

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DPS 1987-05-21

C150-P ECG CABLES

Applicant Desco Industries, Inc.

K number K870926

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DPS 1987-04-09

EK10 ELECTROCARDIOGRAPH

Applicant Burdick Corp.

K number K870880

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DPS 1987-04-09

Q5000 STRESS TEST MONITOR

Applicant Quinton, Inc.

K number K864504

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DPS 1987-03-20

CARDIAN III CR6A

Applicant Cardiac Recorders, Ltd.

K number K864704

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DPS 1987-03-20

CARDIOVIT AT-6

Applicant Schiller Corp.

K number K864465

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DPS 1987-03-16

HORIZON 1100 CARDIAC MONITOR

Applicant Mennen Medical, Inc.

K number K864843

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DPS 1987-03-11

MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03

Applicant Hewlett-Packard Co.

K number K870380

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DPS 1987-02-20

MODEL EL-1 W/ST MONITOR OPTION (ACRONYM = ELI/STM)

Applicant Mortara Instrument, Inc.

K number K864580

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DPS 1987-02-19

ELECTROCARDIOGRAPH

Applicant Nihon Kohden America, Inc.

K number K865031

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DPS 1987-02-19

APPLISCOPE

Applicant Grandcor Medical Systems

K number K864978

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DPS 1987-02-19

Q700 ELECTROCARDIOGRAPH

Applicant Quinton, Inc.

K number K864700

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DPS 1987-02-03

CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR

Applicant Honeywell, Inc.

K number K863100

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DPS 1987-01-12

MINGOGRAF 410

Applicant Siemens Medical Solutions USA, Inc.

K number K864009

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DPS 1987-01-06

MODIFICATION TO DYNASCOPE SERIES MONITORS

Applicant Fukuda Denshi USA, Inc.

K number K863914

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DPS 1987-01-06

LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.

Applicant Computerized Medical Systems, Inc.

K number K863535

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DPS 1986-12-10

MODEL 456 ELECTROCARDIORECORDER RECORDER

Applicant Del Mar Avionics

K number K863652

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DPS 1986-11-20

630C ELECTROCARDIOGRAPH

Applicant Quinton, Inc.

K number K863030

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DPS 1986-11-07

ECG MODULE

Applicant Elscint, Inc.

K number K862553

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DPS 1986-11-06

SERIES 7200 TRANSPORT/REMOTE ACQUISITION MONITOR

Applicant Marquette Electronics, Inc.

K number K860734

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