Electrode, Electrocardiograph

FDA product code DRX · 328 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.2360
Review panel: CV
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-08-23 – 2017-08-23

DRX 1988-01-28

PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D

Applicant Hewlett-Packard Co.

K number K874422

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DRX 1988-01-28

PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A

Applicant Hewlett-Packard Co.

K number K874421

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DRX 1988-01-28

STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE)

Applicant Labeltape Meditect, Inc.

K number K872866

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DRX 1987-12-30

TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE)

Applicant Labeltape Meditect, Inc.

K number K874437

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DRX 1987-12-29

FERRIS ECG ELECTRODE W/HYDROGEL

Applicant Ferris Mfg. Corp.

K number K873682

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DRX 1987-12-07

RESUBMITTED STANDARD MICROPORE ECG ELECTRODE

Applicant Labeltape Meditect, Inc.

K number K874628

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DRX 1987-11-23

ECG ELECTRODE SYSTEM

Applicant Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S

K number K873442

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DRX 1987-10-16

NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)

Applicant Labeltape Meditect, Inc.

K number K872871

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DRX 1987-10-09

MACTRODE-II

Applicant Marquette Electronics, Inc.

K number K872784

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DRX 1987-08-03

ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE

Applicant Nitto Denko America, Inc.

K number K871441

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DRX 1987-06-10

THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE

Applicant The Buddy Systems, Inc.

K number K871748

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DRX 1987-06-10

BIODAN TYPE COMET ELECTRODE

Applicant National Medical Technology

K number K871668

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DRX 1987-06-08

BOWEN REUSEABLE/DISPOSABLE ELECTRODE

Applicant Bowen & Company, Inc.

K number K871325

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DRX 1987-06-05

ELECTROTRACE DISP REST EKG ELECTRODE, CAT. ET1200

Applicant Jason Marketing Co.

K number K871626

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DRX 1987-05-12

CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO

Applicant Contour Electrodes, Inc.

K number K871412

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DRX 1987-05-11

APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)

Applicant Grandcor Medical Systems

K number K864260

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DRX 1987-05-06

ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD

Applicant Multi Biosensors, Inc.

K number K864690

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DRX 1987-04-10

MD MONITORING/DIAGNOSTIC ELECTRODE

Applicant Lectec Corp.

K number K870873

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DRX 1987-03-23

TDK ECG ELECTRODE MEL-10

Applicant Tdk Corp.

K number K870834

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DRX 1987-03-13

PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER

Applicant Labeltape Meditect, Inc.

K number K865011

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DRX 1987-03-13

S&W ELECTRODE TYPES 888, 844, 988 AND 944

Applicant S & W Medico Teknik

K number K864586

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DRX 1987-03-11

TRACETS 2000/ELECTRODES

Applicant Lectec Corp.

K number K863674

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DRX 1987-02-10

MEDI-TRACE INFANT ELECTRODE

Applicant Graphic Controls Corp.

K number K864722

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DRX 1987-01-14

MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK

Applicant Hewlett-Packard Co.

K number K864868

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DRX 1987-01-06

DISPOSABLE ECG MONITORING ELECTRODE

Applicant Clinical Data, Inc.

K number K863904

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DRX 1987-01-06

MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES

Applicant Tdk Corp.

K number K863369

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DRX 1986-12-08

EM II STRESS TEST ELECTRODE

Applicant Electromed Intl., Ltd.

K number K863584

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DRX 1986-12-08

EM II DISPOSABLE ELECTRODE

Applicant Electromed Intl., Ltd.

K number K863540

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DRX 1986-11-21

PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE

Applicant Labeltape Meditect, Inc.

K number K863366

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DRX 1986-11-20

EM III DISPOSABLE ELECTRODE

Applicant Electromed Intl., Ltd.

K number K863845

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DRX 1986-09-15

SKINTACT AG ELECTRODES

Applicant Leon H. Lang Co.

K number K862618

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DRX 1986-08-06

EUROMED S-601

Applicant Lectec Corp.

K number K862765

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DRX 1986-08-06

EM DIAGNOSTIC ECG ELECTRODE

Applicant Electromed Intl., Ltd.

K number K862746

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DRX 1986-08-06

SIGNA II RESTING ECG ELECTRODE

Applicant Kone Instruments, Inc.

K number K862655

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DRX 1986-08-06

PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD

Applicant Conmedcorp

K number K861246

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DRX 1986-08-06

GEREONICS BIOPOTENTIAL SKIN ELECTRODES

Applicant Gereonics, Inc.

K number K861099

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DRX 1986-07-01

S&W TYPE 888 ELECTRODE

Applicant National Medical Technology

K number K861158

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DRX 1986-05-08

EM STRESS ELECTRODE

Applicant Electromed Intl., Ltd.

K number K860827

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DRX 1986-05-08

ECG MONITORING/DEFIBRILLATION ELECTRODE

Applicant Andover Medical, Inc.

K number K854433

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DRX 1986-04-23

5000 SERIES ECG ELECTRODES

Applicant Alternative Design Systems, Inc.

K number K854757

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DRX 1986-04-17

EM ELECTRODE

Applicant Electromed Intl., Ltd.

K number K853774

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DRX 1986-04-11

ECG-ELECTRODE(SWAROMED)

Applicant D. Swarovski & Co.

K number K853939

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DRX 1986-02-28

DOBE (MODIFIED)

Applicant Phoenix Medical Technology, Inc.

K number K853993

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DRX 1986-01-13

BOMED-EEA

Applicant Bomed Medical Mfr., Ltd.

K number K853705

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DRX 1986-01-07

DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES

Applicant Bio-Detek, Inc.

K number K853038

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DRX 1985-10-24

DIAGNOSTIC ECG DISPOSABLE ELECTRODE

Applicant Sentry Medical Products, Inc.

K number K851522

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DRX 1985-09-16

SAF-D-FIB

Applicant Medtronic Andover Medical, Inc.

K number K852469

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DRX 1985-09-16

CARBOCONE

Applicant Imtech Corp.

K number K851732

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DRX 1985-08-09

FOAM ECG ELECTRODES

Applicant Clinical Data, Inc.

K number K852177

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DRX 1985-05-16

SYNKARA

Applicant Lectec Corp.

K number K840445

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DRX 1985-04-09

DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC

Applicant Consolidated Medical Equipment, Inc.

K number K850132

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DRX 1985-04-09

PRN ECG ELECTRODE

Applicant Consolidated Medical Equipment, Inc.

K number K850130

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DRX 1985-03-01

ELECTROCARDIOGRAM DISPOS. ELECTRODE PAD

Applicant Multi Biosensors, Inc.

K number K842514

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DRX 1985-03-01

DISPOSABLE ECG ELECTRODE

Applicant Bristol Medical Electronics Corp.

K number K841944

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DRX 1985-02-27

DISPOSABLE ECG ELECTRODES EASATRACE

Applicant Medical Device Marketing

K number K850085

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DRX 1985-02-20

ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON

Applicant Bristol Medical Electronics Corp.

K number K844856

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DRX 1985-01-14

INFANT LIMB ELECTRODE

Applicant Sentry Medical Products, Inc.

K number K844632

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DRX 1985-01-02

CONTOUR ELECTRODE

Applicant Heuristic Medical Systems, Inc.

K number K844345

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DRX 1985-01-02

ELECTROCARDIOGRAPH ELECTRODE

Applicant Meditect

K number K844335

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DRX 1984-12-27

CANMED 101

Applicant Medtronic Vascular

K number K844100

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DRX 1984-12-27

CANMED 102

Applicant Medtronic Vascular

K number K844099

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DRX 1984-10-26

CARDIOTRODE

Applicant Kholber Corp.

K number K840646

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DRX 1984-06-19

Q-MED ELECTRODE

Applicant Qmed, Inc.

K number K840465

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DRX 1984-05-23

ESOPHOGRAL MULTIPROBE

Applicant Vital Signs, Inc.

K number K832903

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DRX 1984-05-09

CARDIO TRACE ELECTRODE

Applicant Poly-Med Splint Co.

K number K832429

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DRX 1984-04-01

MEDI-TRACE QUIKSET DX DIAG. ELECT-

Applicant Graphic Controls Corp.

K number K834445

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DRX 1984-02-10

TDK ECG ELECTRODE MEL-08

Applicant Tdk Corp.

K number K833899

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DRX 1984-01-27

ADULT MONITORING ELECTOR@@RODE 9431-300

Applicant Marquette Electronics, Inc.

K number K833695

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DRX 1983-12-22

PRE-GELLED DISPOS ELECTRODE

Applicant Advance Tech Intl.

K number K832877

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DRX 1983-12-16

MAGNATRODE CARDIAC MONITORING ELECTRODE

Applicant R2 Corp.

K number K832516

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DRX 1983-09-09

C TEC SERIES 9000 E.C.G. ELECTRODE

Applicant Speywood Medical, Ltd.

K number K831977

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DRX 1983-06-15

QUIK-SILVER RESTING ECG ELECTRODE

Applicant Quinton, Inc.

K number K830655

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DRX 1983-06-03

INFANT ELECTRODE BELT

Applicant Sentry Medical Products, Inc.

K number K830362

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DRX 1983-04-28

PENCIL SKIN ABRADER

Applicant Ndm Corp.

K number K830663

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DRX 1982-11-01

MEDI-TRACE 5' OFFSET ELECTRODE

Applicant Graphic Controls Corp.

K number K822750

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DRX 1982-10-15

DISPOSABLE ELECTRODE #1900

Applicant Andover Medical, Inc.

K number K822798

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DRX 1982-07-30

LDS MONITORING ELECTRODE

Applicant Life Design Systems, Inc.

K number K821846

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DRX 1982-07-30

CENTURION ELECTRODE BELT

Applicant Clinical Data, Inc.

K number K821802

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DRX 1982-07-30

EKG (ECG) ELECTRODES

Applicant Dupaco, Inc.

K number K821434

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DRX 1982-07-08

VITALINE DISPOSABLE EKG ELECTRODE-LEAD

Applicant The Halverstadt Co.

K number K821535

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DRX 1982-07-02

QUIK - PREP2 ELECTRODE

Applicant Quinton, Inc.

K number K821757

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DRX 1982-06-17

MEDICOTEST ECG ELECTRODES

Applicant Medicotest, Inc.

K number K821506

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DRX 1982-05-25

RED DOT MONITORING ELECTRODES #2260/65

Applicant 3M Company

K number K821438

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DRX 1982-05-18

MEDITRACE PELLET ELECTRODE

Applicant Graphic Controls Corp.

K number K821137

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DRX 1982-03-01

PIONEER II BACK PLATE ELECTRODE

Applicant Life Science Instrumentation, Inc.

K number K820122

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DRX 1981-12-29

GEL ELECTRODE

Applicant Dyn-A-Med Products

K number K813176

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DRX 1981-11-27

GEL ELECTRODE

Applicant Arndt Automation & Assoc.

K number K813013

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DRX 1981-11-02

THE NEW 1600 ELECTRODE

Applicant Andover Medical, Inc.

K number K812878

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DRX 1981-09-25

DISPOSABLE ELECTRODE, #1610

Applicant Andover Medical, Inc.

K number K812276

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DRX 1981-05-13

ESOPHAGEAL PILL ELECTRODE

Applicant Con Med Equipment, Inc.

K number K810895

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DRX 1981-03-17

QUINTON LTE ELECTRODE

Applicant Quinton, Inc.

K number K810563

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DRX 1981-03-11

DISPOSABLE ELECTRODE FOR EKG

Applicant Midwest Monitoring

K number K803179

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DRX 1981-01-29

ADULT ECG ELECTRODE #60-0724

Applicant Aspen Laboratories, Inc.

K number K810103

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DRX 1981-01-29

INFANT ECG ELECTRODE #60-1029

Applicant Aspen Laboratories, Inc.

K number K810102

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DRX 1980-11-12

EXTERNAL JUGULAR CVP CATHERIZATION KIT

Applicant Willson

K number K802576

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DRX 1980-09-09

ELECTROCARDIOGRAPH ELECTRODE

Applicant Phoenix Glove Co.

K number K801846

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DRX 1980-05-23

R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS)

Applicant R2 Corp.

K number K800935

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DRX 1980-05-23

R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.

Applicant R2 Corp.

K number K800930

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DRX 1980-02-26

ESOPHAGEAL PILL-ELECTRODE

Applicant Arzbaecher & Co.

K number K800201

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DRX 1980-02-22

VXTRA BACK PACK EKG ELECTRODE CAT. NO.

Applicant Vxtra Corp.

K number K792436

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