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
241–264 of 329
Cleared Apr 23, 1986
5000 SERIES ECG ELECTRODES
K854757
Alternative Design Systems, Inc.
Cardiovascular · 147d
Cleared Apr 17, 1986
EM ELECTRODE
K853774
Electromed Intl., Ltd.
Cardiovascular · 219d
Cleared Apr 11, 1986
ECG-ELECTRODE(SWAROMED)
K853939
D. Swarovski & Co.
Cardiovascular · 199d
Cleared Feb 28, 1986
DOBE (MODIFIED)
K853993
Phoenix Medical Technology, Inc.
Cardiovascular · 154d
Cleared Jan 13, 1986
BOMED-EEA
K853705
Bomed Medical Mfr., Ltd.
Cardiovascular · 131d
Cleared Jan 07, 1986
DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES
K853038
Bio-Detek, Inc.
Cardiovascular · 172d
Cleared Oct 24, 1985
DIAGNOSTIC ECG DISPOSABLE ELECTRODE
K851522
Sentry Medical Products, Inc.
Cardiovascular · 192d
Cleared Sep 16, 1985
CARBOCONE
K851732
Imtech Corp.
Cardiovascular · 144d
Cleared Sep 16, 1985
SAF-D-FIB
K852469
Medtronic Andover Medical, Inc.
Cardiovascular · 95d
Cleared Aug 09, 1985
FOAM ECG ELECTRODES
K852177
Clinical Data, Inc.
Cardiovascular · 81d
Cleared May 16, 1985
SYNKARA
K840445
Lectec Corp.
Cardiovascular · 472d
Cleared Apr 09, 1985
PRN ECG ELECTRODE
K850130
Consolidated Medical Equipment, Inc.
Cardiovascular · 85d
Cleared Apr 09, 1985
DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC
K850132
Consolidated Medical Equipment, Inc.
Cardiovascular · 85d
Cleared Mar 01, 1985
DISPOSABLE ECG ELECTRODE
K841944
Bristol Medical Electronics Corp.
Cardiovascular · 294d
Cleared Mar 01, 1985
ELECTROCARDIOGRAM DISPOS. ELECTRODE PAD
K842514
Multi Biosensors, Inc.
Cardiovascular · 248d
Cleared Feb 27, 1985
DISPOSABLE ECG ELECTRODES EASATRACE
K850085
Medical Device Marketing
Cardiovascular · 47d
Cleared Feb 20, 1985
ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON
K844856
Bristol Medical Electronics Corp.
Cardiovascular · 68d
Cleared Jan 14, 1985
INFANT LIMB ELECTRODE
K844632
Sentry Medical Products, Inc.
Cardiovascular · 48d
Cleared Jan 02, 1985
ELECTROCARDIOGRAPH ELECTRODE
K844335
Meditect
Cardiovascular · 56d
Cleared Jan 02, 1985
CONTOUR ELECTRODE
K844345
Heuristic Medical Systems, Inc.
Cardiovascular · 54d
Cleared Dec 27, 1984
CANMED 102
K844099
Medtronic Vascular
Cardiovascular · 65d
Cleared Dec 27, 1984
CANMED 101
K844100
Medtronic Vascular
Cardiovascular · 65d
Cleared Oct 26, 1984
CARDIOTRODE
K840646
Kholber Corp.
Cardiovascular · 254d
Cleared Jun 19, 1984
Q-MED ELECTRODE
K840465
Qmed, Inc.
Cardiovascular · 137d