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
25–48 of 329
Cleared Nov 14, 2002
SKINTACT ECG ELECTRODE
K023503
Leonhard Lang GmbH
Cardiovascular · 27d
Cleared Nov 07, 2002
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
K020003
Bio Protech, Inc.
Cardiovascular · 309d
Cleared Aug 18, 2000
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
K002230
Cambridge Heart, Inc.
Cardiovascular · 25d
Cleared Aug 15, 2000
V QUICK PATCH
K993934
Vq Corp.
Cardiovascular · 271d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
K990110
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
K990111
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
K990112
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560
K990113
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440
K990115
Maersk Medical A/S
Cardiovascular · 327d
Cleared Nov 26, 1999
ECG ELECTRODE (VARIOUS)
K991105
Conmedcorp
Cardiovascular · 239d
Cleared Oct 26, 1999
SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES
K982521
Leonhard Lang Co.
Cardiovascular · 463d
Cleared Jan 15, 1999
BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES
K983689
Medicotest A/S
Cardiovascular · 87d
Cleared Nov 13, 1998
MEDI-TRACE 4103 NEONATAL ELECTRODE
K981964
Graphic Controls Corp.
Cardiovascular · 162d
Cleared Oct 14, 1998
ECG ELECTRODES APRON
K982470
Tapuz Medical Technology , Ltd.
Cardiovascular · 90d
Cleared Jul 26, 1998
3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360
K974445
3M Healthcare
Cardiovascular · 243d
Cleared Feb 10, 1998
PALJET-B
K973663
Golden Gate Bio-Device
Cardiovascular · 138d
Cleared Dec 19, 1997
ELECTRODE, ELECTROCARDIOGRAPH
K973727
Don Tay Industries
Cardiovascular · 80d
Cleared Jul 08, 1997
NICAS(TM) ELECTRODE
K972001
Ni Medical
Cardiovascular · 39d
Cleared Jun 11, 1997
3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES
K971444
3M Medical Products Group
Cardiovascular · 51d
Cleared Apr 15, 1997
STEALTHSHIELD
K970755
Vital Connections, Inc.
Cardiovascular · 43d
Cleared Apr 09, 1997
3M RED DOT 2560 & 2570 MONITORING ELECTRODES
K970796
3M Healthcare
Cardiovascular · 36d
Cleared Mar 11, 1997
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM
K963787
Conmedcorp
Cardiovascular · 172d
Cleared Mar 04, 1997
NOAH MONITORING ELECTRODE SYSTEM
K970125
Contour Medical Technology, Inc.
Cardiovascular · 49d
Cleared Jan 07, 1997
VERSATEC 310 ELECTRODE
K963975
Versatec, Inc.
Cardiovascular · 96d