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
265–288 of 329
Cleared May 23, 1984
ESOPHOGRAL MULTIPROBE
K832903
Vital Signs, Inc.
Cardiovascular · 268d
Cleared May 09, 1984
CARDIO TRACE ELECTRODE
K832429
Poly-Med Splint Co.
Cardiovascular · 292d
Cleared Apr 01, 1984
MEDI-TRACE QUIKSET DX DIAG. ELECT-
K834445
Graphic Controls Corp.
Cardiovascular · 107d
Cleared Feb 10, 1984
TDK ECG ELECTRODE MEL-08
K833899
Tdk Corp.
Cardiovascular · 88d
Cleared Jan 27, 1984
ADULT MONITORING ELECTOR@@RODE 9431-300
K833695
Marquette Electronics, Inc.
Cardiovascular · 101d
Cleared Dec 22, 1983
PRE-GELLED DISPOS ELECTRODE
K832877
Advance Tech Intl.
Cardiovascular · 118d
Cleared Dec 16, 1983
MAGNATRODE CARDIAC MONITORING ELECTRODE
K832516
R2 Corp.
Cardiovascular · 141d
Cleared Sep 09, 1983
C TEC SERIES 9000 E.C.G. ELECTRODE
K831977
Speywood Medical, Ltd.
Cardiovascular · 81d
Cleared Jun 15, 1983
QUIK-SILVER RESTING ECG ELECTRODE
K830655
Quinton, Inc.
Cardiovascular · 105d
Cleared Jun 03, 1983
INFANT ELECTRODE BELT
K830362
Sentry Medical Products, Inc.
Cardiovascular · 120d
Cleared Apr 28, 1983
PENCIL SKIN ABRADER
K830663
Ndm Corp.
Cardiovascular · 56d
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
EKG (ECG) ELECTRODES
K821434
Dupaco, Inc.
Cardiovascular · 79d
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 08, 1982
VITALINE DISPOSABLE EKG ELECTRODE-LEAD
K821535
The Halverstadt Co.
Cardiovascular · 45d
Cleared Jul 02, 1982
QUIK - PREP2 ELECTRODE
K821757
Quinton, Inc.
Cardiovascular · 17d
Cleared Jun 17, 1982
MEDICOTEST ECG ELECTRODES
K821506
Medicotest, Inc.
Cardiovascular · 27d
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 Dec 29, 1981
GEL ELECTRODE
K813176
Dyn-A-Med Products
Cardiovascular · 47d
Cleared Nov 27, 1981
GEL ELECTRODE
K813013
Arndt Automation & Assoc.
Cardiovascular · 31d