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
145–168 of 329
Cleared May 26, 1992
BR-50-J DISPOSABLE ECG ELECTRODE
K921579
Medicotest, Inc.
Cardiovascular · 54d
Cleared Apr 10, 1992
EME MP3000 MONITORING AND DIAGNOSTIC RESTING ECG
K920867
Electro Medical Equipment Co., Inc.
Cardiovascular · 45d
Cleared Oct 31, 1991
QR-50-E DISPOSABLE RADIOTRANSLUCENT ECG ELECTRODE
K914672
Medicotest, Inc.
Cardiovascular · 13d
Cleared Oct 10, 1991
BIO-SENSOR 01 EKG ELECTRODE
K911472
Bio-Sensor, Inc.
Cardiovascular · 190d
Cleared Oct 10, 1991
VER-MED A10020 RESTING EKG ELECTRODE
K911687
Vermont Medical, Inc.
Cardiovascular · 177d
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 Aug 15, 1991
VER-MED A10014 RESTING EKG ELECTRODE & A10021
K910139
Vermont Medical, Inc.
Cardiovascular · 213d
Cleared Jul 25, 1991
RT40 RADIO TRANSLUCENT
K912714
Bio-Detek, Inc.
Cardiovascular · 37d
Cleared Jun 21, 1991
ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.
K911990
Somnitec, Inc.
Cardiovascular · 46d
Cleared Apr 22, 1991
RESTING EKG ELECTRODE SERIES
K910494
Medtronic Andover Medical, Inc.
Cardiovascular · 76d
Cleared Mar 21, 1991
VER-MED A10017 UNIVERSAL ELECTRODE
K905489
Vermont Medical, Inc.
Cardiovascular · 104d
Cleared Feb 07, 1991
CANMED 451
K905729
Andover Medical, Inc.
Cardiovascular · 45d
Cleared Feb 05, 1991
MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE
K905446
Medtronic Andover Medical, Inc.
Cardiovascular · 62d
Cleared Jan 31, 1991
TRACET AG 4000
K904512
Lectec Corp.
Cardiovascular · 121d
Cleared Dec 17, 1990
MONITRODE
K903491
Lleventon
Cardiovascular · 136d
Cleared Nov 05, 1990
ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC.
K903555
Jason Marketing Co.
Cardiovascular · 90d
Cleared Oct 31, 1990
MODEL 1850 ELECTRODE
K903918
Medtronic Vascular
Cardiovascular · 68d
Cleared Oct 31, 1990
SENSATRACE
K904185
Ludlow Corp., Technical Papers Division
Cardiovascular · 49d
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
Cleared Jul 31, 1990
NF-50-E DISPOSABLE ECG ELECTRODE
K902407
Medicotest, Inc.
Cardiovascular · 61d
Cleared Jul 18, 1990
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
K901555
Medtronic Vascular
Cardiovascular · 106d
Cleared Jul 18, 1990
RED DOT 2269 INFANT MONITORING ELECTRODE
K902080
3M Company
Cardiovascular · 71d