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
313–329 of 329
Cleared Oct 06, 1978
PREGELLED DISPOSABLE ELECTRODE
K781518
Vente Medical Products, Inc.
Cardiovascular · 36d
Cleared Sep 26, 1978
ELECTRODE, DEIP.
K781163
Datascope Corp.
Cardiovascular · 76d
Cleared Jun 19, 1978
SELF-RETAINING ELECTRODE SER. #4000-100
K780908
Andover Medical, Inc.
Cardiovascular · 14d
Cleared Nov 09, 1977
ECG CLUSTER ELECTRODE
K771776
C.R. Bard, Inc.
Cardiovascular · 51d
Cleared Aug 16, 1977
ACCU-TRODE (DISP. ECG ELECTRODE)
K771392
Warner/Chilcott
Cardiovascular · 19d
Cleared Aug 04, 1977
PREGELLED DISP. EKG MONITORING ELECT-
K771447
Hayes Products, Inc.
Cardiovascular · 2d
Cleared Jun 14, 1977
FOAM ECG ELECTRODE, 2060 AND 2061
K770988
Cardio-Dynamics Laboratories, Inc.
Cardiovascular · 14d
Cleared Mar 29, 1977
ELECTROCARDIOGRAPHIC ELECTRODES, DISP.
K770521
Dobre, Inc.
Cardiovascular · 11d
Cleared Feb 01, 1977
LIFEPATCH TM ECG ELECTRODE
K770083
Physio-Control Corp.
Cardiovascular · 18d
Cleared Jan 05, 1977
V-TRACE ECG BACKPAD
K761301
Ndm Corp.
Cardiovascular · 14d
Cleared Dec 21, 1976
RADIO TRANSPARENT ECG ELECTRODE
K761249
Concept, Inc.
Cardiovascular · 8d
Cleared Aug 23, 1976
ELECTRODE SERIES 1401
K760280
Andover Medical, Inc.
Cardiovascular · 31d
Cleared Aug 23, 1976
ELECTRODE SERIES 1600
K760358
Andover Medical, Inc.
Cardiovascular · 21d