DRX · Class II · 21 CFR 870.2360

FDA Product Code DRX: Electrode, Electrocardiograph

Leading manufacturers include Graphic Controls Corp., Nikomed U.S.A., Inc. and Lectec Corp..

329
Total
329
Cleared
123d
Avg days
1976
Since
329 devices
217–240 of 329
Cleared May 11, 1987
APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)
K864260
Grandcor Medical Systems
Cardiovascular · 194d
Cleared May 06, 1987
ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD
K864690
Multi Biosensors, Inc.
Cardiovascular · 155d
Cleared Apr 10, 1987
MD MONITORING/DIAGNOSTIC ELECTRODE
K870873
Lectec Corp.
Cardiovascular · 38d
Cleared Mar 23, 1987
TDK ECG ELECTRODE MEL-10
K870834
Tdk Corp.
Cardiovascular · 20d
Cleared Mar 13, 1987
S&W ELECTRODE TYPES 888, 844, 988 AND 944
K864586
S & W Medico Teknik
Cardiovascular · 112d
Cleared Mar 13, 1987
PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER
K865011
Labeltape Meditect, Inc.
Cardiovascular · 80d
Cleared Mar 11, 1987
TRACETS 2000/ELECTRODES
K863674
Lectec Corp.
Cardiovascular · 173d
Cleared Feb 10, 1987
MEDI-TRACE INFANT ELECTRODE
K864722
Graphic Controls Corp.
Cardiovascular · 69d
Cleared Jan 14, 1987
MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK
K864868
Hewlett-Packard Co.
Cardiovascular · 33d
Cleared Jan 06, 1987
MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES
K863369
Tdk Corp.
Cardiovascular · 166d
Cleared Jan 06, 1987
DISPOSABLE ECG MONITORING ELECTRODE
K863904
Clinical Data, Inc.
Cardiovascular · 91d
Cleared Dec 08, 1986
EM II DISPOSABLE ELECTRODE
K863540
Electromed Intl., Ltd.
Cardiovascular · 88d
Cleared Dec 08, 1986
EM II STRESS TEST ELECTRODE
K863584
Electromed Intl., Ltd.
Cardiovascular · 84d
Cleared Nov 21, 1986
PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE
K863366
Labeltape Meditect, Inc.
Cardiovascular · 79d
Cleared Nov 20, 1986
EM III DISPOSABLE ELECTRODE
K863845
Electromed Intl., Ltd.
Cardiovascular · 50d
Cleared Sep 15, 1986
SKINTACT AG ELECTRODES
K862618
Leon H. Lang Co.
Cardiovascular · 68d
Cleared Aug 06, 1986
GEREONICS BIOPOTENTIAL SKIN ELECTRODES
K861099
Gereonics, Inc.
Cardiovascular · 135d
Cleared Aug 06, 1986
PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD
K861246
Conmedcorp
Cardiovascular · 132d
Cleared Aug 06, 1986
SIGNA II RESTING ECG ELECTRODE
K862655
Kone Instruments, Inc.
Cardiovascular · 23d
Cleared Aug 06, 1986
EM DIAGNOSTIC ECG ELECTRODE
K862746
Electromed Intl., Ltd.
Cardiovascular · 16d
Cleared Aug 06, 1986
EUROMED S-601
K862765
Lectec Corp.
Cardiovascular · 15d
Cleared Jul 01, 1986
S&W TYPE 888 ELECTRODE
K861158
National Medical Technology
Cardiovascular · 95d
Cleared May 08, 1986
ECG MONITORING/DEFIBRILLATION ELECTRODE
K854433
Andover Medical, Inc.
Cardiovascular · 184d
Cleared May 08, 1986
EM STRESS ELECTRODE
K860827
Electromed Intl., Ltd.
Cardiovascular · 64d