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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 1986-10-16

PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART

Applicant Analogic Corp.

K number K860646

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DPS 1986-09-23

SPACELABS SERIES 90700 PATIENT MONITORS

Applicant Spacelabs, Inc.

K number K862951

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DPS 1986-09-17

CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH)

Applicant Nihon Kohden America, Inc.

K number K863116

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DPS 1986-08-28

SIEMENS-ELEMA (SICARD-P)

Applicant Mortara Instrument, Inc.

K number K861851

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DPS 1986-08-28

BURDICK DIVISION (E-500)

Applicant Mortara Instrument, Inc.

K number K861850

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DPS 1986-08-25

MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION

Applicant Cambridge Medical Instruments, Inc.

K number K862748

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DPS 1986-08-25

CIRCADIAN STRESS TEST SYSTEM

Applicant Circadian, Inc.

K number K860973

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DPS 1986-08-06

KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH

Applicant Suzuken Co., Ltd.

K number K862544

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DPS 1986-08-01

MICROCOR E.C.G. MONITOR WITH A.C. ADAPTER

Applicant Microcor, Inc.

K number K861281

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DPS 1986-07-17

FUTUREMED ECG SYSTEM 500

Applicant Futuremed Div. of Future Impex Corp.

K number K862381

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DPS 1986-07-15

SIEMENS SIRECUST MODELS 403P,403-2P & 403N

Applicant Analogic Corp.

K number K855096

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DPS 1986-06-09

MODEL 43200A CARDIAC MONITOR

Applicant Hewlett-Packard Co.

K number K861992

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DPS 1986-06-05

PARAGON 420, CARDIAC MONITOR

Applicant Life Sensing Instrument Company, Inc.

K number K861067

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DPS 1986-05-16

CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM

Applicant Hewlett-Packard Co.

K number K861359

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DPS 1986-05-09

FASTRACE III, ECG ELECTRODE

Applicant Andover Medical, Inc.

K number K860636

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DPS 1986-05-08

BIOMECCA CARETAKER 1000 & 2000

Applicant Biomecca Australia , Ltd.

K number K860790

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DPS 1986-05-07

PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A

Applicant Ivy Biomedical Systems, Inc.

K number K854840

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DPS 1986-04-17

CARDIOFAX ECG-6353

Applicant Nihon Kohden America, Inc.

K number K860212

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DPS 1986-04-15

CD-200 CARDIAC MONITOR

Applicant Cardio Display Corp.

K number K860175

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DPS 1986-03-11

THE HOLTER REPORTER (TM)

Applicant Applied Cardiac Systems

K number K860249

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DPS 1986-02-26

CARDISUNY 501 A

Applicant Atrix

K number K852829

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DPS 1986-02-06

CARDIMAX FX-1164

Applicant Brentwood Instruments, Inc.

K number K853979

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DPS 1986-01-21

ESCORT ECG MONITOR SIEMENS SIRECUST 466

Applicant Medical Data Electronics

K number K854234

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DPS 1985-12-30

EKG 503A

Applicant Bosch Hearing Instruments, Inc.

K number K840571

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DPS 1985-12-30

EKG 501 A

Applicant Bosch Hearing Instruments, Inc.

K number K840569

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DPS 1985-11-14

LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR

Applicant Logos Medical Co., Ltd.

K number K851662

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DPS 1985-10-09

SCHILLER MINISCOPE MS-2 EKG SCOPE

Applicant Armstrong Ind., Inc.

K number K852282

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DPS 1985-10-09

SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER

Applicant Armstrong Ind., Inc.

K number K852281

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DPS 1985-10-09

ELECTROCARDIOGRAPH

Applicant Armstrong Ind., Inc.

K number K852181

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DPS 1985-09-11

VSM-5

Applicant Physio-Control Corp.

K number K852322

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DPS 1985-09-09

REMOTE CONTROL MODULE

Applicant Circadian, Inc.

K number K851643

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DPS 1985-08-01

CARIOLINE(ELECTROCARDIOGRAPH)

Applicant Remco Italia S.P.A.

K number K852770

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DPS 1985-06-26

CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL

Applicant Eaton Medical Group

K number K851633

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DPS 1985-06-26

CARDIOSTAT 3 RECORDER

Applicant Siemens Elema AB

K number K851044

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DPS 1985-05-16

PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH

Applicant Parexel Intl. Corp.

K number K851322

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DPS 1985-05-16

TELEMETRY SOFTWARE FOR G-2000 ELECTROCARDIOGRAPH

Applicant Eaton Medical Group

K number K850323

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DPS 1985-05-16

RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH

Applicant Eaton Medical Group

K number K850322

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DPS 1985-04-25

CARDIOVIT CS-6 ECG-RECORDER

Applicant Schiller AG

K number K850702

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DPS 1985-04-11

CARDIOSTAT 1 ECG RECORDER

Applicant Siemens Elema AB

K number K844392

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DPS 1985-04-09

CARDIO-NEC MODEL 365

Applicant Birtcher Corp.

K number K844101

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DPS 1985-03-01

CARDIO-3 CHANNEL ELECTROCARDIOGRAPH

Applicant Zimmer Elektromedizin GmbH

K number K850454

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DPS 1985-03-01

MONITORING SYSTEM M720

Applicant Burdick Corp.

K number K842944

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DPS 1985-02-08

ELECTROCARDIOGRAPH-ECG CALIPER

Applicant Devcom, Inc.

K number K850021

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DPS 1985-02-06

SURGICAL MODULE 7000 ECG

Applicant Marquette Electronics, Inc.

K number K840869

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DPS 1985-01-24

CARDIOVIT CV-3

Applicant Schiller AG

K number K841254

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DPS 1985-01-23

CARDIO IV/GXT STRESS TESTING SYSTEM

Applicant Intl. Medical, Inc.

K number K844744

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DPS 1985-01-10

FUKUDA DENSHI MODEL FCP-220

Applicant Brentwood Instruments, Inc.

K number K844470

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DPS 1984-11-20

MODEL {M-102 I-CHANNEL ELECTRO CARDIOGRAPH UNIT

Applicant Future Impex Corp.

K number K843934

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DPS 1984-10-26

FITNESS LOGGER

Applicant Britt Corp., Inc.

K number K840020

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DPS 1984-08-03

ELECTROCARDIOGRAPH E-340

Applicant Burdick Corp.

K number K840440

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DPS 1984-08-02

QUINTON 901 & 900 HOLTER SCANNER

Applicant Quinton, Inc.

K number K841611

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DPS 1984-05-09

E 310 ELECTROCARDIOGRAPH

Applicant Burdick Corp.

K number K833951

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DPS 1984-05-09

FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN

Applicant Brentwood Instruments, Inc.

K number K833593

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DPS 1984-04-17

MINI PECG-MODIFICATION

Applicant Intersect Systems, Inc.

K number K841148

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DPS 1984-01-30

VITAL SIGNS MONITOR 3

Applicant Physio-Control Corp.

K number K833584

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DPS 1984-01-18

ECG INTERFERENCE FILTER TF-03

Applicant La Jolla Technology, Inc.

K number K832888

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DPS 1983-12-16

BATTERY-OPERATED ELECTROCARDIOGRAPH

Applicant Somatronix Research Corp.

K number K832421

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DPS 1983-12-13

MORTARA INSTRUMENT #101

Applicant Mortara Instrument, Inc.

K number K832050

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DPS 1983-12-06

MINI-PECG

Applicant Intersect Systems, Inc.

K number K832883

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DPS 1983-12-01

G-2000

Applicant Eaton Medical Group

K number K832227

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DPS 1983-11-14

CASE-II

Applicant Marquette Electronics, Inc.

K number K833458

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DPS 1983-11-07

PACEMAKER EVALUATION MODULE-330

Applicant Marquette Electronics, Inc.

K number K833470

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DPS 1983-10-31

SIMPLISCRIPTOR EK 31/101 037 16

Applicant Litton Medical Electronics

K number K832184

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DPS 1983-10-31

MULTISCRIPTOR EK 36/101 047 02,05

Applicant Litton Medical Electronics

K number K832130

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DPS 1983-10-31

MULTISCRIPTOR EK VARIOUS #43

Applicant Litton Medical Electronics

K number K832015

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DPS 1983-10-31

MULTISCRIPTOR EK #403 VARIOUS MODEL

Applicant Litton Medical Electronics

K number K832014

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DPS 1983-10-31

LME PATIENT MONITOR SMS 151

Applicant Litton Medical Electronics

K number K832013

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DPS 1983-10-14

PATIENT SELECTOR FUNCTION BLOCK

Applicant Honeywell, Inc.

K number K832212

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DPS 1983-10-14

AS 191 ECG TELEMETRY MODULE

Applicant Narco Scientific

K number K831429

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DPS 1983-09-29

CARDIO-SCOPE MINI MONITOR

Applicant W.E. Leder Enterprises, Inc.

K number K831878

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DPS 1983-07-18

APNEA/BRADYCARDIA MONITOR HB 95

Applicant Harvey-Bostwick, Inc.

K number K830666

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DPS 1983-06-22

UNIVERSAL MEDDARS SYSTEM

Applicant Electronics For Medicine, Inc.

K number K830791

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DPS 1983-05-25

CONVERTER UNIT FOR ECG TRACE DISPLAY

Applicant Honeywell, Inc.

K number K830566

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DPS 1982-12-30

FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO-

Applicant Brentwood Instruments, Inc.

K number K823584

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DPS 1982-12-30

ELECTROCARDIOGRAPH #334

Applicant Birtcher Corp.

K number K823488

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DPS 1982-12-22

MODEL RM 6000, 6100,6200 POLYGRAPH

Applicant Nihon Kohden America, Inc.

K number K823281

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DPS 1982-12-15

FULL-DISCLOSURE AMBULATORY ECG SYSTEM

Applicant Clinical Data, Inc.

K number K823529

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DPS 1982-11-24

COSMOS

Applicant Nihon Kohden America, Inc.

K number K823220

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DPS 1982-10-04

ELECTROCARDIOGRAPH (74 DPS) #YM-102

Applicant Sanyo Electric, Inc.

K number K822768

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DPS 1982-09-21

QUIKPAGE SCANNER

Applicant Agilent Technologies

K number K822582

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DPS 1982-08-25

QUINTON Q, SCAN MODELS 900 & 901

Applicant Quinton, Inc.

K number K821758

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DPS 1982-07-30

AUTOMATIC SINGLE CHANNEL ECG #399

Applicant Birtcher Corp.

K number K821888

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DPS 1982-07-08

CARDI-O-LIFE MODEL 8823

Applicant Amertek

K number K821090

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DPS 1982-04-21

HOLTER ECG SCANNER

Applicant Laser Scan Corp.

K number K820014

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DPS 1982-02-12

ELECTROENCEPHALOGRAPH ECG-6151

Applicant Nihon Kohden America, Inc.

K number K820067

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DPS 1982-01-22

CARDIOSTRESS

Applicant Instruments For Cardiac Research

K number K820011

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DPS 1981-12-14

ELECTROCARDIOGRAPH CM3000

Applicant Philips Medical Systems (Cleveland), Inc.

K number K813279

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DPS 1981-12-14

FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-36

Applicant Brentwood Instruments, Inc.

K number K813021

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DPS 1981-12-02

FUKUDA DENSHI CARDIMAX FK-12

Applicant Brentwood Instruments, Inc.

K number K813022

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DPS 1981-08-13

KENL-ECG

Applicant Suzuken Co., Ltd.

K number K811950

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DPS 1981-08-13

KENL-ECG-3

Applicant Suzuken Co., Ltd.

K number K811949

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DPS 1981-07-16

BIOVISION CARDIAC STROBE

Applicant Cardiac Imaging

K number K811341

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DPS 1981-06-30

CENTRAL STATION MONITORING SYSTEMS

Applicant Cambridge Instruments, Inc.

K number K811121

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DPS 1981-05-01

CC-100

Applicant Anthro-Metrics Corp.

K number K811016

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DPS 1981-05-01

IBM 5885 DIGITAL ECG ACQUISITION CART

Applicant Intl. Business Machines

K number K810988

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DPS 1981-03-27

PHYSIOLOGIC RECORDER

Applicant Honeywell, Inc.

K number K810696

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DPS 1981-03-26

LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM

Applicant Physio-Control Corp.

K number K810154

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DPS 1981-03-11

STRESS TEST SYSTEM

Applicant Nihon Kohden America, Inc.

K number K810357

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DPS 1981-03-04

OPTION 301 PACEMAKER EVAL. MODULE MAC-1

Applicant Marquette Electronics, Inc.

K number K802368

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DPS 1981-02-25

ECG FUNCTION BLOCK

Applicant Honeywell, Inc.

K number K810176

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