DRX · Class II · 21 CFR 870.2360

FDA Product Code DRX: Electrode, Electrocardiograph

Leading manufacturers include Graphic Controls Corp., Lectec Corp. and Labeltape Meditect, Inc..

329
Total
329
Cleared
123d
Avg days
1976
Since
329 devices
145–168 of 329
Cleared Jan 07, 1986
DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES
K853038
Bio-Detek, Inc.
Cardiovascular · 172d
Cleared Aug 09, 1985
FOAM ECG ELECTRODES
K852177
Clinical Data, Inc.
Cardiovascular · 81d
Cleared May 16, 1985
SYNKARA
K840445
Lectec Corp.
Cardiovascular · 472d
Cleared Dec 27, 1984
CANMED 102
K844099
Medtronic Vascular
Cardiovascular · 65d
Cleared Dec 27, 1984
CANMED 101
K844100
Medtronic Vascular
Cardiovascular · 65d
Cleared May 23, 1984
ESOPHOGRAL MULTIPROBE
K832903
Vital Signs, Inc.
Cardiovascular · 268d
Cleared Apr 01, 1984
MEDI-TRACE QUIKSET DX DIAG. ELECT-
K834445
Graphic Controls Corp.
Cardiovascular · 107d
Cleared Jan 27, 1984
ADULT MONITORING ELECTOR@@RODE 9431-300
K833695
Marquette Electronics, Inc.
Cardiovascular · 101d
Cleared Jun 15, 1983
QUIK-SILVER RESTING ECG ELECTRODE
K830655
Quinton, Inc.
Cardiovascular · 105d
Cleared Nov 01, 1982
MEDI-TRACE 5' OFFSET ELECTRODE
K822750
Graphic Controls Corp.
Cardiovascular · 49d
Cleared Oct 15, 1982
DISPOSABLE ELECTRODE #1900
K822798
Andover Medical, Inc.
Cardiovascular · 29d
Cleared Jul 30, 1982
CENTURION ELECTRODE BELT
K821802
Clinical Data, Inc.
Cardiovascular · 45d
Cleared Jul 30, 1982
LDS MONITORING ELECTRODE
K821846
Life Design Systems, Inc.
Cardiovascular · 38d
Cleared Jul 02, 1982
QUIK - PREP2 ELECTRODE
K821757
Quinton, Inc.
Cardiovascular · 17d
Cleared May 25, 1982
RED DOT MONITORING ELECTRODES #2260/65
K821438
3M Company
Cardiovascular · 12d
Cleared May 18, 1982
MEDITRACE PELLET ELECTRODE
K821137
Graphic Controls Corp.
Cardiovascular · 28d
Cleared Mar 01, 1982
PIONEER II BACK PLATE ELECTRODE
K820122
Life Science Instrumentation, Inc.
Cardiovascular · 42d
Cleared Nov 02, 1981
THE NEW 1600 ELECTRODE
K812878
Andover Medical, Inc.
Cardiovascular · 19d
Cleared Sep 25, 1981
DISPOSABLE ELECTRODE, #1610
K812276
Andover Medical, Inc.
Cardiovascular · 43d
Cleared Mar 17, 1981
QUINTON LTE ELECTRODE
K810563
Quinton, Inc.
Cardiovascular · 14d
Cleared Jan 29, 1981
INFANT ECG ELECTRODE #60-1029
K810102
Aspen Laboratories, Inc.
Cardiovascular · 13d
Cleared Jan 29, 1981
ADULT ECG ELECTRODE #60-0724
K810103
Aspen Laboratories, Inc.
Cardiovascular · 13d
Cleared Nov 13, 1979
BARD BIOMEDICAL PRINTED SILVER ELECTRODE
K792040
C.R. Bard, Inc.
Cardiovascular · 32d
Cleared Jun 01, 1979
ECG ELECTRODES, PEDIATRIC-FOAM TAPE
K791002
Physio-Control Corp.
Cardiovascular · 3d