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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 1981-02-19

MICROPROCESSOR CONTROLLED ELECTROCARDIO

Applicant Honeywell, Inc.

K number K810263

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DPS 1981-01-29

ECG ARRHYTHMIA STIMULATOR

Applicant Belmont Instrument Corp.

K number K810104

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DPS 1981-01-22

SIRECUST 400 SYSTEM PATIENT MONITORING

Applicant Analogic Corp.

K number K802113

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DPS 1981-01-16

VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH

Applicant Advanced Technology Laboratories, Inc.

K number K803309

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DPS 1981-01-07

MODEL HEC-7 HEART EVALUATION COMPUTER

Applicant Kluwe Corp.

K number K802952

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DPS 1980-11-26

MODEL 4700A ELECTROCARDIOGRAPH

Applicant Hewlett-Packard Co.

K number K802718

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DPS 1980-10-23

MODEL 633A THREE CHANNEL STRESS TEST

Applicant Quinton, Inc.

K number K802190

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DPS 1980-08-07

ELECTROCARDIOGRAPH, MODEL ECG-5503

Applicant Nihon Kohden America, Inc.

K number K801677

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DPS 1980-04-08

SCHILLER MSG-1

Applicant Renesco International, Inc.

K number K800659

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DPS 1980-04-08

CAMBRIDGE VS-550 ELECTROCARDIOGRAPH

Applicant Cambridge Instruments, Inc.

K number K800566

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DPS 1980-04-02

SIRECUST 311S

Applicant Siemens Corp.

K number K800593

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DPS 1980-03-18

VSM-1 PHYSIOLOGICAL MONITOR

Applicant Physio-Control Corp.

K number K800492

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DPS 1980-03-05

ECG MONITOR OSCILLOSCOPE MODEL OEC-3100

Applicant Nihon Kohden America, Inc.

K number K800005

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DPS 1980-03-05

ECG MONITOR OSCILLOSCOPE MODEL OEC-3200

Applicant Nihon Kohden America, Inc.

K number K800004

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DPS 1979-11-21

ELECTROCARDIOGRAPH, MODEL ECG-5151

Applicant Nihon Kohden America, Inc.

K number K792229

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DPS 1979-11-05

MODEL 685/686 DYNAMIC ELECTROCARDI0-

Applicant Del Mar Avionics

K number K792072

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DPS 1979-09-27

COMP-ACT IV

Applicant Medcraft Corp.

K number K791795

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DPS 1979-09-17

SCINTISTRESS SYSTEM

Applicant Cambridge Instruments, Inc.

K number K791201

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DPS 1979-09-04

ELECTROCARDIOGRAPH MODEL ECG-5403

Applicant Nihon Kohden America, Inc.

K number K791540

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DPS 1979-08-28

MINISCOPE MS-2B ELECTROCARDIOSCOPE

Applicant Renesco International, Inc.

K number K791421

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DPS 1979-08-28

MINIGRAPH MG-I ELECTROCARDIOGRAPH

Applicant Renesco International, Inc.

K number K791420

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DPS 1979-08-03

QUINTON MODEL 630 AND 636 ECG DATA CART

Applicant Quinton, Inc.

K number K791364

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DPS 1979-07-30

ECG CHANNEL OF DIAGNOSTIC SYSTEM

Applicant Honeywell, Inc.

K number K791151

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DPS 1979-06-11

MODEL 78501A PATIENT MONITORING SYSTEM

Applicant Hewlett-Packard Co.

K number K790939

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DPS 1979-05-31

SIEMENS CARDIOSTAT 701

Applicant Elmed, Inc.

K number K790794

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DPS 1979-05-17

CARDIO-SLIDECOMP

Applicant Creative Instruments

K number K790869

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DPS 1979-04-26

QUINTON MODEL 530X ECG DATA CART

Applicant Quinton, Inc.

K number K790739

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DPS 1979-04-16

25-50 EKG RULER

Applicant Medical Engineering Designs Co., Inc.

K number K790691

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DPS 1979-03-27

META III

Applicant Hittman Medical Systems

K number K790300

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DPS 1979-02-08

ELECTROCARDIOGRAPH, AT-300 3 CHANNEL

Applicant Health Technology Laboratories, Inc.

K number K790233

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DPS 1979-02-08

ELECTROCARDIOGRAPH, EK-9

Applicant Burdick Corp.

K number K790114

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DPS 1978-12-12

MONITOR/MINI SCOPE

Applicant Ipco Corp.

K number K781679

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DPS 1978-07-27

LIFELINE AMBULATORY

Applicant Imc

K number K781054

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DPS 1978-05-19

CARDIAC MINIGRAPH

Applicant Arco Medical Products Co.

K number K780307

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DPS 1978-02-21

STRESS TEST SYSTEM

Applicant Quinton, Inc.

K number K780166

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DPS 1978-02-17

EK-670

Applicant Burdick Corp.

K number K780138

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DPS 1977-11-03

ELAPSED TIME INDICATOR MODEL 21361A

Applicant Hewlett-Packard Co.

K number K771380

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DPS 1977-06-03

PORTASCOPE II

Applicant Mennen Greatbatch Electonics

K number K770832

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DPS 1977-05-06

MONITOR, PORTABLE, PATIENT, G.E.

Applicant General Electric Co.

K number K770760

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DPS 1977-03-01

ISOLATED ELECTROCARDIOGRAPH MODEL 1207

Applicant Electronics For Medicine, Inc.

K number K770366

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DPS 1977-01-31

SIMULATOR, 10 LEAD ECG

Applicant Birtcher Corp.

K number K761023

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DPS 1977-01-14

ELECTROCARDIOGRAPH MODEL 344

Applicant Birtcher Corp.

K number K770037

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DPS 1976-12-09

MODEL 3044 3-CHANNEL STRESS TEST SYSTEM

Applicant Cambridge Instruments, Inc.

K number K761198

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DPS 1976-12-06

CARDIART 108T/313

Applicant Conway Electronic Enterprises , Ltd.

K number K761014

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DPS 1976-11-15

ELECTROCARDIOGRAPH, EK-7 (3-CHANNELS)

Applicant Burdick Corp.

K number K760271

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DPS 1976-11-12

THREE-CHANNEL STRESS TEST SYSTEM (M633)

Applicant Quinton, Inc.

K number K760854

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DPS 1976-11-12

CIRCUIT, PRINTED, SERVO-MECHANISM

Applicant Burdick Corp.

K number K760272

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DPS 1976-11-12

ELECTROCARDIOGRAPH EK-6 W/OPTIONAL CIRC.

Applicant Burdick Corp.

K number K760268

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DPS 1976-11-09

ELECTROCARDIOGRAPH (MODEL VS-4B)

Applicant Cambridge Instruments, Inc.

K number K760926

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DPS 1976-10-13

MONITOR, ELECTROCARDIOSCOPE

Applicant Burdick Corp.

K number K760266

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DPS 1976-10-05

LIFEPAK 5 CARDIOSCOPE MODULE (NPN 5)

Applicant Physio-Control Corp.

K number K760677

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DPS 1976-09-21

SPACELABS SERIES 1000

Applicant Spacelabs, Inc.

K number K760612

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DPS 1976-09-09

ELECTROCARDIOGRAPH (#1505A)

Applicant Hewlett-Packard Co.

K number K760542

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DPS 1976-08-30

MONITORING SYSTEM, REHABILITATION

Applicant Medcraft Corp.

K number K760510

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DPS 1976-08-30

STRESS SYSTEM, 3-CHANNEL (#21127A)

Applicant Hewlett-Packard Co.

K number K760465

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DPS 1976-08-30

STRESS SYSTEM, SINGLE-CHANNEL (#21125)

Applicant Hewlett-Packard Co.

K number K760463

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DPS 1976-08-23

ELCTROCARDIOGRAPH, EK-6

Applicant Burdick Corp.

K number K760265

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DPS 1976-07-19

MONITOR, PATIENT (MODEL 78331A)

Applicant Hewlett-Packard Co.

K number K760150

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