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
49–72 of 329
Cleared Dec 11, 1996
CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES
K963159
Cmc Sense-It, Inc.
Cardiovascular · 119d
Cleared Dec 09, 1996
MEDICOTEST ECG ELECTRODES
K961643
Medicotest, Inc.
Cardiovascular · 224d
Cleared Nov 25, 1996
TRACE RITE SOLID GEL ECG ELECTRODES
K964213
Bio-Detek, Inc.
Cardiovascular · 34d
Cleared Nov 19, 1996
MEDI-TRACE 5700 RESTING ECG ELECTRODE
K963151
Graphic Controls Corp.
Cardiovascular · 102d
Cleared Nov 15, 1996
MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE
K963038
Graphic Controls Corp.
Cardiovascular · 102d
Cleared Oct 28, 1996
MEDI-TRACE 200, MEDI-TRACE 200-30
K960968
Graphic Controls Corp.
Cardiovascular · 231d
Cleared Aug 29, 1996
CAMBRIDGE HEART HI-RES ECG ELECTRODE
K962115
Cambridge Heart, Inc.
Cardiovascular · 90d
Cleared Aug 08, 1996
BODYTRODE
K961288
Marquette Electronics, Inc.
Cardiovascular · 126d
Cleared Jul 24, 1996
SENTRY RADIOTRANSLUCENT ECG ELECTRODES
K962122
Sentry Medical Products, Inc.
Cardiovascular · 54d
Cleared Jul 23, 1996
G3000 OR AG2000
K955815
Cmc Sense-It, Inc.
Cardiovascular · 210d
Cleared Jul 18, 1996
PACEART WRIST ELECTRODES
K960721
Paceart, Inc.
Cardiovascular · 147d
Cleared Jul 11, 1996
QUICKELS QS 200 SYSTEM
K954772
Ferguson Medical
Cardiovascular · 272d
Cleared Jul 11, 1996
QUICKELS QS 100 SYSTEM
K954773
Ferguson Medical
Cardiovascular · 272d
Cleared Jun 21, 1996
DISPOSABLE ECG ELECTRODE
K953649
Kendall-Ltp
Cardiovascular · 322d
Cleared Jun 07, 1996
MEDI-TRACE RADIOLUCENT
K961395
Graphic Controls Corp.
Cardiovascular · 57d
Cleared May 17, 1996
UNILECT, MONITAB AND BIOTRACE-HR
K944497
Msb , Ltd.
Cardiovascular · 612d
Cleared May 17, 1996
SI2000 (SENSE-IT TRADEMARK) OR G2000
K955800
Cmc Sense-It, Inc.
Cardiovascular · 147d
Cleared May 16, 1996
BIOTRACE-N, NS, 410 AND RT
K944496
Msb , Ltd.
Cardiovascular · 611d
Cleared May 16, 1996
CONMED ECG/EKG ELECTRODES
K954389
Conmedcorp
Cardiovascular · 240d
Cleared Apr 09, 1996
CONMED EKG STRIPPER
K960264
Conmedcorp
Cardiovascular · 82d
Cleared Feb 06, 1996
CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE
K954388
Conmedcorp
Cardiovascular · 140d
Cleared Jul 07, 1995
MEDI-TRACE(R) 500 ECG ELECTRODE
K945479
Graphic Controls Corp.
Cardiovascular · 241d
Cleared Jul 07, 1995
GRAPHIC CONTROLS PROTRACE ECG ELECTRODE
K950485
Graphic Controls Corp.
Cardiovascular · 151d
Cleared Jul 03, 1995
GRAPHIC CONTROLS BIOTAC ECO ELECTRODE
K950488
Graphic Controls Corp.
Cardiovascular · 147d