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
73–96 of 329
Cleared Jul 03, 1995
GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE
K950489
Graphic Controls Corp.
Cardiovascular · 147d
Cleared May 17, 1995
GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE
K950486
Graphic Controls Corp.
Cardiovascular · 100d
Cleared May 17, 1995
GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE
K950487
Graphic Controls Corp.
Cardiovascular · 100d
Cleared Feb 24, 1995
EKG VEST
K932903
Cardiotronics, Inc.
Cardiovascular · 618d
Cleared Feb 03, 1995
QUIK COMBO
K943301
Physio-Control Corp.
Cardiovascular · 210d
Cleared Nov 22, 1994
TRIGEL MULTIFUNCTION ELECTRODE
K934505
Physiometrix, Inc.
Cardiovascular · 433d
Cleared Nov 10, 1994
MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE
K945214
Graphic Controls Corp.
Cardiovascular · 16d
Cleared Aug 03, 1994
K-KLIP
K940801
Katecho, Inc.
Cardiovascular · 162d
Cleared Jun 22, 1994
ZIPPREP ELECTRODE
K940802
Aspect Medical Systems, Inc.
Cardiovascular · 120d
Cleared Jun 09, 1994
K-SNAP
K940586
Katecho, Inc.
Cardiovascular · 121d
Cleared Sep 01, 1993
3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE
K930312
3M Health Care, Ltd.
Cardiovascular · 222d
Cleared Aug 16, 1993
3M RED DOT 2330 RESTING EKG ELECTRODE
K932454
3M Health Care, Ltd.
Cardiovascular · 87d
Cleared Apr 16, 1993
TRACET T-6000
K930258
Lectec Corp.
Cardiovascular · 87d
Cleared Mar 18, 1993
MODEL 1300 SOFTRACE II ELECTRODE
K921164
Medtronic Vascular
Cardiovascular · 372d
Cleared Feb 18, 1993
ECG ELECTRODE
K923558
Lectec Corp.
Cardiovascular · 216d
Cleared Oct 13, 1992
DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION
K921207
Physiometrix, Inc.
Cardiovascular · 215d
Cleared Sep 04, 1991
MODEL #810 STEALTH-STIM ADULT STIMULATION PADS
K913226
Cardiotronics, Inc.
Cardiovascular · 47d
Cleared Aug 28, 1991
TRACETS SME 5000
K912450
Lectec Corp.
Cardiovascular · 86d
Cleared Jul 25, 1991
RT40 RADIO TRANSLUCENT
K912714
Bio-Detek, Inc.
Cardiovascular · 37d
Cleared Feb 07, 1991
CANMED 451
K905729
Andover Medical, Inc.
Cardiovascular · 45d
Cleared Jan 31, 1991
TRACET AG 4000
K904512
Lectec Corp.
Cardiovascular · 121d
Cleared Oct 31, 1990
MODEL 1850 ELECTRODE
K903918
Medtronic Vascular
Cardiovascular · 68d
Cleared Sep 04, 1990
SILVER MACTRODE
K902176
Marquette Electronics, Inc.
Cardiovascular · 112d
Cleared Sep 04, 1990
ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH
K902738
Labeltape Meditect, Inc.
Cardiovascular · 75d