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.

ECLIPSE 4 ELECTROCARDIOGRAPH

FDA product code LOS · 83 cleared devices

Unclassified

Clearance span: 1978-01-06 – 2009-08-26

LOS 2009-08-26

EKG-PLUS II SOFTWARE

Applicant Bionet Co., Ltd.

K number K090895

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LOS 2009-03-10

CARDIOVIEW32 REVIEW MODULE

Applicant Qrs Diagnostic, LLC

K number K083749

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LOS 2008-04-11

PHILIPS ECG ALGORITHM

Applicant Philips Medical Systems

K number K073376

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LOS 2002-11-14

CARDIOTOUCH-3000

Applicant Bionet Company, Ltd.

K number K023034

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LOS 2001-11-21

CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH

Applicant Bionet Company, Ltd.

K number K011328

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LOS 2000-04-10

CARDIO-CARD INTERPRETATION SYSTEM I

Applicant Nasiff Assoc., Inc.

K number K993616

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LOS 1999-10-27

OXYCONALPHA WITH OPTION ECG

Applicant Erich Jaeger B.V.

K number K984465

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LOS 1999-10-20

CASE 8000 EXERCISE TESTING SYSTEM

Applicant General Electric Medical Systems Information Techn

K number K991014

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LOS 1999-08-19

MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS

Applicant General Electric Medical Systems Information Techn

K number K991735

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LOS 1999-04-16

NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES

Applicant Nihon Kohden America, Inc.

K number K990031

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LOS 1999-04-15

NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES

Applicant Nihon Kohden America, Inc.

K number K984504

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LOS 1999-02-02

MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE

Applicant Micromedical Industries, Ltd.

K number K990266

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LOS 1998-10-06

QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM)

Applicant Marquette Medical Systems, Inc.

K number K981024

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LOS 1998-09-08

CARDIOVIEW 3000 SOFTWARE

Applicant Micromedical, Inc.

K number K974352

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LOS 1998-08-31

FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH

Applicant Fukuda Denshi USA, Inc.

K number K981066

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LOS 1998-08-21

ELECTROCARDIOGRAPHS

Applicant Dr. Lee Co., Ltd.

K number K972587

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LOS 1998-07-07

PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM

Applicant Pulse Biomedical, Inc.

K number K972255

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LOS 1998-06-23

PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA

Applicant Hewlett-Packard Co.

K number K981265

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LOS 1998-06-15

MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT

Applicant Hewlett-Packard Co.

K number K974087

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LOS 1998-05-12

ARCHIMED 4210 AND 4220

Applicant Biosound Esaote, Inc.

K number K973922

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LOS 1998-05-07

MUSE CARDIOVASCULAR INFORMATION SYSTEM

Applicant Marquette Medical Systems, Inc.

K number K980495

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LOS 1998-03-12

CARDIOSMART ST

Applicant Marquette Medical Systems, Inc.

K number K973403

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LOS 1998-02-06

ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION

Applicant Marquette Medical Systems, Inc.

K number K974199

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LOS 1997-12-02

FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH

Applicant Fukuda Denshi USA, Inc.

K number K971440

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LOS 1997-06-25

CARDIOVIT CS-200

Applicant Schiller America, Inc.

K number K970879

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LOS 1997-02-21

EAGLE 4000 PATIENT MONITOR

Applicant Marquette Electronics, Inc.

K number K964750

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LOS 1997-01-27

HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT

Applicant Cardio Control BV

K number K962854

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LOS 1996-12-10

MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS

Applicant Criticare Systems, Inc.

K number K961223

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LOS 1996-11-01

NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES

Applicant Nihon Kohden America, Inc.

K number K961272

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LOS 1996-07-31

QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH

Applicant Quinton, Inc.

K number K961014

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LOS 1996-05-15

PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO

Applicant Hewlett-Packard Co.

K number K954980

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LOS 1996-04-23

ECLIPSE 4 ELECTROCARDIOGRAPH

Applicant Burdick, Inc.

K number K946281

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LOS 1996-04-04

CARDIOSOFT/CARDIOSYS

Applicant Marquette Electronics, Inc.

K number K951130

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LOS 1996-01-04

HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INSENSITIVE PREDICITIVE INSTRUMENT (ACI-TIPT)

Applicant Hewlett-Packard Co.

K number K951978

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LOS 1995-12-19

CARDIOVIT AT-1C, AT-2C

Applicant Schiller America, Inc.

K number K953396

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LOS 1995-08-24

CENTRA HEART STATION

Applicant Marquette Electronics, Inc.

K number K935589

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LOS 1995-05-26

ECG FAX MODEM

Applicant Hewlett-Packard Co.

K number K941282

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LOS 1995-05-19

CARDIOVIT AT-5C

Applicant Schiller America, Inc.

K number K941462

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LOS 1995-05-17

ECLIPSE 4 ELECTROCARDIOGRAPH

Applicant Burdick, Inc.

K number K943959

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LOS 1994-07-26

HP M177XA CARDIOGRAPHS

Applicant Hewlett-Packard Co.

K number K935772

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LOS 1994-04-15

MODEL ELI 300 ELECTROCARDIOGRAPH

Applicant Mortara Instrument, Inc.

K number K933143

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LOS 1994-03-01

CARDIOFAX Q ECG-8420A

Applicant Nihon Kohden America, Inc.

K number K922394

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LOS 1993-12-06

SPACE LABS MODEL 90560

Applicant Spacelabs, Inc.

K number K923788

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LOS 1993-11-01

CARDIO PERFECT, CARDIO PERFECT MD

Applicant Cardio Control BV

K number K922898

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LOS 1993-05-07

MARQUETTE SL SERIES TRANSPORT REMOTE ACQUISITION

Applicant Marquette Electronics, Inc.

K number K921669

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LOS 1993-04-21

SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM

Applicant Del Mar Avionics

K number K922221

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LOS 1992-11-10

MORTARA INSTRUMENT ODEL ELI 50I

Applicant Mortara Instrument, Inc.

K number K915730

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LOS 1992-11-03

CARDIOVIT CS-100

Applicant Schiller America, Inc.

K number K914970

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LOS 1992-10-21

INTERP-1000

Applicant Qmed, Inc.

K number K921476

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LOS 1992-10-09

ELITE II ELECTROCARDIOGRAPH,MODIFIED

Applicant Siemens Burdick, Inc.

K number K915327

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LOS 1992-09-04

MODEL ELI 100 ELECTROCARDIOGRAPH

Applicant Mortara Instrument, Inc.

K number K920627

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LOS 1992-09-04

MODEL ELI 200 ELECTROCARDIOGRAPH

Applicant Mortara Instrument, Inc.

K number K920626

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LOS 1992-07-07

SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM

Applicant Stuart Medical, Inc.

K number K920294

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LOS 1992-07-01

MEGACART

Applicant Siemens Burdick, Inc.

K number K915225

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LOS 1992-06-10

SPECTRA ECG

Applicant Advanced Medical Products, Inc.

K number K915658

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LOS 1992-05-15

INTERNAL MODEM FOR THE E560 ELECTROCARDIOGRAPH

Applicant Siemens Burdick, Inc.

K number K915202

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LOS 1992-04-28

MORTARA INSTRUMENT MODEL ECG PREVU

Applicant Mortara Instrument, Inc.

K number K920377

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LOS 1992-03-26

E350I ELECTROCARDIOGRAPH

Applicant Siemens Burdick, Inc.

K number K914969

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LOS 1992-02-14

LIKEPAK 11 CARDIAC MONIT/LIFENET RS100 REC STATION

Applicant Physio-Control Corp.

K number K912189

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LOS 1991-12-27

SERIES 1500 12-LEAD ANALYSIS OPTION

Applicant Marquette Electronics, Inc.

K number K903644

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LOS 1991-12-09

FUKUDA DENSHI MODEL FCP-4101

Applicant Fukuda Denshi USA, Inc.

K number K913811

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LOS 1991-09-05

WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L)

Applicant Wex Medical Instrumentation Co.

K number K901619

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LOS 1991-07-24

ELITE II ELECTROCARDIOGRAPH

Applicant Burdick Corp.

K number K904032

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LOS 1991-07-24

E560 ELECTROCARDIOGRAPH

Applicant Burdick Corp.

K number K903565

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LOS 1990-09-06

SMALL JOINT INSTRUMENTS (SCISSOR HANDLE)

Applicant Leonard Medical, Inc.

K number K903536

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LOS 1990-07-17

PAGEWRITER XLI M1700A & PAGEWRITER XL M1701A

Applicant Hewlett-Packard Co.

K number K895520

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LOS 1990-04-04

CARDISUNY, 501BX

Applicant Graham-Field, Inc.

K number K900849

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LOS 1989-12-13

MODEL ELI-100/ST ELECTROCARDIOGRAPH

Applicant Mortara Instrument, Inc.

K number K895232

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LOS 1989-11-30

SPACELABS MODEL 90900

Applicant Spacelabs, Inc.

K number K894093

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LOS 1989-10-02

FUKUDA DENSHI MODEL FCP-2201

Applicant Fukuda Denshi USA, Inc.

K number K892796

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LOS 1989-02-23

Q750 ELECTROCARDIOGRAPH

Applicant Quinton, Inc.

K number K885000

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LOS 1989-02-23

HIGH RESOLUTION OPTION FOR MAC SERIES ELECTROCARDI

Applicant Marquette Electronics, Inc.

K number K884087

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LOS 1987-07-01

KENZ-CARDICO 1201

Applicant Suzuken Co., Ltd.

K number K870443

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LOS 1987-05-07

MINGOGRAF 740 - MODEL #91-54-634

Applicant Siemens Medical Solutions USA, Inc.

K number K864575

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LOS 1987-04-13

ELITE ELECTROCARDIOGRAPH

Applicant Burdick Corp.

K number K870920

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LOS 1985-03-06

CARDIO ANALYZER MODEL 380

Applicant Birtcher Corp.

K number K844104

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LOS 1985-01-18

MODEL 503FB

Applicant Atrix

K number K842759

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LOS 1984-11-13

N-CHANNEL

Applicant Philips Medical Systems (Cleveland), Inc.

K number K834212

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LOS 1984-09-21

12SSL-SC

Applicant Marquette Electronics, Inc.

K number K842308

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LOS 1982-04-15

MARQUETTE OPTION II ECG ANALYSIS COMPUT

Applicant Marquette Electronics, Inc.

K number K820885

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LOS 1981-05-01

IBM 5880 ACQUISITION & ANALYSIS CART TEL

Applicant Intl. Business Machines

K number K810989

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LOS 1980-11-12

12SSL ECG ANALYSIS PROG.(SCALER LEAD)

Applicant Marquette Electronics, Inc.

K number K802369

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LOS 1978-01-06

EKG ACQUISITION & ANALYSIS CART

Applicant Intl. Business Machines

K number K772353

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