Detector And Alarm, Arrhythmia

FDA product code DSI · 385 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1025
Review panel: CV
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-12-09 – 2026-01-23

DSI 1985-07-26

MEDILOG M1

Applicant Oxford Medilog, Inc.

K number K852884

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DSI 1985-07-26

MEDILOG M3

Applicant Oxford Medilog, Inc.

K number K852883

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DSI 1985-07-11

KENZ 80Z MARK II

Applicant Suzuken Co., Ltd.

K number K843731

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DSI 1985-06-11

OXFORD VDT-40 DISPLAY TERMINAL

Applicant Oxford Medilog, Inc.

K number K852207

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DSI 1985-04-10

FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES

Applicant Fukuda Denshi USA, Inc.

K number K850897

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DSI 1985-04-10

SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A

Applicant Analogic Corp.

K number K844791

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DSI 1985-04-03

PROGRAMMABLE PATIENT SIMULATOR

Applicant Ramford Labs

K number K844464

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DSI 1985-03-01

BRENTWOOD EZ SCAN 200 AMBULATORY ECG

Applicant Brentwood Instruments, Inc.

K number K842976

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DSI 1985-02-07

QUIKPAGE ARRHYTHMIA REPORT GENERATOR

Applicant Agilent Technologies

K number K841083

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DSI 1985-02-01

CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM

Applicant Cardio Data

K number K850136

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DSI 1985-02-01

ARRHYTHMIA SYSTEM AC-11

Applicant Fukuda Denshi USA, Inc.

K number K841084

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DSI 1985-01-10

HORIZON ECG SYSTEM

Applicant Beckman Instruments, Inc.

K number K823844

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DSI 1984-11-20

SERVOMED ARRHYCOMP CENTRAL MONITOR SYS

Applicant Litton Medical Electronics

K number K840899

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DSI 1984-11-19

DOCUMENTOR

Applicant Life Technology

K number K842715

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DSI 1984-11-16

PERSONAL CL SINGLE-CHANNEL ELECTROCAR

Applicant Parexel Intl. Corp.

K number K842123

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DSI 1984-10-26

AEGIS AMBULATORY MONITORING SYSTEM

Applicant Aegis Medical Systems, Inc.

K number K843503

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DSI 1984-10-22

EPICARDIA, PC

Applicant Medicomp, Inc.

K number K843513

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DSI 1984-10-18

ARRHYTHMIA CENTRAL OCC-7101

Applicant Nihon Kohden America, Inc.

K number K843287

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DSI 1984-10-18

SPACELABS ALPHA PC PATIENT COMPUTER

Applicant Spacelabs, Inc.

K number K842616

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DSI 1984-10-18

PEDIATRIC DIAG. CRITERIA OPTION 5600C

Applicant Hewlett-Packard Co.

K number K841416

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DSI 1984-10-04

SPACELABS ICR ARRHYTHMIA MASTER I HOLTER

Applicant Spacelabs, Inc.

K number K842640

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DSI 1984-08-28

LIFESCOPE 6 OEC-6201

Applicant Nihon Kohden America, Inc.

K number K841500

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DSI 1984-07-27

MONITOR ONE

Applicant Qmed, Inc.

K number K841172

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DSI 1984-07-02

CARDIO EXPRESS 100 HOLTER SCANNER

Applicant Del Mar Avionics

K number K840622

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DSI 1984-06-05

LEAP FROG

Applicant Philips Medical Systems (Cleveland), Inc.

K number K834211

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DSI 1984-04-17

ALPHA MASS STORAGE CARDULE 1895

Applicant Spacelabs, Inc.

K number K834597

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DSI 1984-04-17

HOLTER CARDIOGRAPHY SYS 6201

Applicant Instruments For Cardiac Research

K number K834397

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DSI 1984-01-27

HOLTA-MED INFORMER PLAYBACK

Applicant Holta-Med

K number K832354

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DSI 1984-01-10

AMBULATORY MONITORING DEVICE

Applicant Oxford Medilog, Inc.

K number K833162

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DSI 1983-12-01

BIOSENSOR ASC SYSTEM

Applicant Biosensor Corp.

K number K831676

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DSI 1983-11-14

SINGLE BED ARRHYTHMIA MONITOR AM500

Applicant Lifeline Systems, Inc.

K number K831638

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DSI 1983-11-07

ARRHYTHMIA III CARDULE #1919

Applicant Spacelabs, Inc.

K number K832693

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DSI 1983-11-03

SATURN-24HR. HOLTER SCANNER

Applicant Hittman Medical Systems

K number K832772

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DSI 1983-10-27

WLECTROCARDIOGRAPH ECG-7204

Applicant Nihon Kohden America, Inc.

K number K831274

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DSI 1983-06-18

CIRCA MED TWO-CHANNEL

Applicant Circadian, Inc.

K number K830830

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DSI 1983-04-06

COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200

Applicant Brentwood Instruments, Inc.

K number K823586

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DSI 1983-04-06

COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13

Applicant Brentwood Instruments, Inc.

K number K823585

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DSI 1983-03-31

SIRECUST 400

Applicant Analogic Corp.

K number K830029

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DSI 1983-03-24

ECLIPSE

Applicant Diagnostic Medical Instruments

K number K830407

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DSI 1983-03-17

HEARTRATE PLUS ECG CARDULE #1918

Applicant Spacelabs, Inc.

K number K830306

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DSI 1983-02-28

EPI CARDIA SYS. - AMBULATORY MONITOR

Applicant Medicomp, Inc.

K number K830013

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DSI 1983-02-18

IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS

Applicant Intl. Business Machines

K number K830163

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DSI 1982-12-15

ELECTROCARDIOGRAPH INTERPRETER

Applicant Suzuken Co., Ltd.

K number K822968

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DSI 1982-10-18

LS6 ARRYTHMIA DISCRIMINATOR

Applicant Life Science Instrumentation, Inc.

K number K822616

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DSI 1982-10-04

SERIES 7000 BEDSIDE PATIENT MONITOR

Applicant Marquette Electronics, Inc.

K number K822718

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DSI 1982-10-04

CARDIO TEHCHANALYZER

Applicant Cardio Technology , Ltd.

K number K821711

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DSI 1982-09-28

MULTIPLE LEAD ARRHYTHMIA MODULE

Applicant Marquette Electronics, Inc.

K number K822030

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DSI 1982-05-18

MEMOPORT C

Applicant Litton Medical Electronics

K number K820881

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DSI 1982-04-29

EVENTMASTER 2

Applicant Instruments For Cardiac Research

K number K820856

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DSI 1982-04-29

QUINTON Q2000 ETT MONITORING SYSTEM

Applicant Quinton, Inc.

K number K820438

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DSI 1982-04-15

ALGORITHM OF THE ARRHYTHMIA MON. SYS

Applicant Hewlett-Packard Co.

K number K820477

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DSI 1981-12-29

MICRO-PREPROCESSOR UNIT

Applicant General Electric Co.

K number K812914

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DSI 1981-12-14

CC-201 ECG MONITORING SYSTEMS

Applicant Anthro-Metrics Corp.

K number K813287

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DSI 1981-08-31

CARDIO-DATA SYSTEM, #MARK III

Applicant Cardio Data

K number K812149

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DSI 1981-08-13

ARRHYTHMIA FUNCTION BLOCK

Applicant Honeywell, Inc.

K number K811581

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DSI 1981-07-16

THE BETA

Applicant Burdick Corp.

K number K810940

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DSI 1981-07-10

ARRYTHMIA PRINTER OPTION

Applicant American Edwards Laboratories

K number K811792

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DSI 1981-06-16

CC-103

Applicant Anthro-Metrics Corp.

K number K811527

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DSI 1981-06-12

DEL MAR AVIONICS MODELS 9400 & 9401

Applicant Del Mar Avionics

K number K811122

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DSI 1981-05-27

SIRECUST 358

Applicant Siemens Corp.

K number K803208

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DSI 1981-03-26

DATAMEDIX PECGASYS SYSTEM

Applicant Datamedix

K number K810027

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DSI 1981-03-11

HEART SENTINEL

Applicant Totemite Medical Electronics

K number K802900

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DSI 1981-03-11

SERIES 4000 STRESS & EXERCISE SYSTEM

Applicant Instruments For Cardiac Research

K number K801903

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DSI 1981-02-27

GUARDIAN MONITOR (CARDIOVASCULAR)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K803282

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DSI 1981-01-07

CC101 ECG MONITORING SYSTEM

Applicant Anthro-Metrics Corp.

K number K802312

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DSI 1980-11-26

BIOMETRIC ERG SYSTEM

Applicant Biometric Analysis Group, Inc.

K number K802472

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DSI 1980-09-26

COMPUTER ECG TERMINAL

Applicant Compumed, Inc.

K number K802272

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DSI 1980-09-26

ECG RECALL & EDIT PRODUCT VERSION-A3601

Applicant General Electric Co.

K number K802103

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DSI 1980-09-26

OXFORD INTENSIVE CARE PATIENT MON. SYS

Applicant Oxford Medilog, Inc.

K number K802033

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DSI 1980-09-09

EVALUATOR #9500 DYNAMIC ELEC/SCANNER

Applicant Del Mar Avionics

K number K801831

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DSI 1980-08-27

MICRO-PROCESSOR UNIT #A3600AC

Applicant General Electric Co.

K number K801762

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DSI 1979-11-13

SPECTRA CENTRAL PT MONITORING SYS

Applicant American Optical Corp.

K number K792081

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DSI 1979-11-13

COMPU-SCAN

Applicant Hittman Medical Systems

K number K791632

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DSI 1979-08-28

MODEL 78520A ARRHYTHMIA MONITORING SYS

Applicant Hewlett-Packard Co.

K number K791487

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DSI 1979-08-28

DCG-VII ELECTROCARDIOSCANNER

Applicant Del Mar Avionics

K number K791424

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DSI 1979-05-16

ARRHYTHMIA II CARDULE

Applicant Spacelabs, Inc.

K number K790837

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DSI 1979-02-28

ANALYZER, MEDILOG II

Applicant Oxford Medilog, Inc.

K number K790287

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DSI 1978-11-30

ECG ANALYZER, HIGH SPEED

Applicant Cardio-Dynamics Laboratories, Inc.

K number K781911

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DSI 1978-11-20

CAMSCAN SYSTEM

Applicant American Optical Corp.

K number K781845

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DSI 1978-05-26

ARRHYTHMIA PROGRAM MODULE

Applicant Midwest Analog & Digital, Inc.

K number K780432

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DSI 1978-04-18

ARRHYTHMIA TREND ENHANCEMENT

Applicant American Optical Corp.

K number K780343

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DSI 1978-01-12

ARRHYTHMIA MODULE

Applicant General Electric Co.

K number K772360

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DSI 1977-08-04

SCANNER TREND SYSTEM

Applicant Instruments For Cardiac Research

K number K771374

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DSI 1977-02-28

MONITORING & STRESS TESTING EQUIPMENT

Applicant Advanced Medical, Inc.

K number K760368

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DSI 1976-12-09

MICRO-COMPUTER ARRHYTHONIA SYSTEM

Applicant Spacelabs, Inc.

K number K760884

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