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
193–216 of 329
Cleared Oct 06, 1988
BARD MULTI-TAC ECG MONITORING ELECTRODE
K884064
C.R. Bard, Inc.
Cardiovascular · 10d
Cleared Oct 05, 1988
TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5
K882904
Tdk Corp.
Cardiovascular · 85d
Cleared Jul 20, 1988
SYNCOR (R) MODEL S-801 ECG ELECTRODE
K882216
Lectec Corp.
Cardiovascular · 55d
Cleared Apr 11, 1988
SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE
K881085
Contour Electrodes, Inc.
Cardiovascular · 34d
Cleared Jan 28, 1988
STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE)
K872866
Labeltape Meditect, Inc.
Cardiovascular · 191d
Cleared Jan 28, 1988
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A
K874421
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Jan 28, 1988
PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D
K874422
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Jan 28, 1988
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E
K874423
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Jan 28, 1988
PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E
K874424
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Jan 28, 1988
SECURATRODE
K874562
Meddev International Corp.
Cardiovascular · 85d
Cleared Jan 28, 1988
TRACETS 3000
K875015
Lectec Corp.
Cardiovascular · 55d
Cleared Jan 28, 1988
FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE
K875041
Labeltape Meditect, Inc.
Cardiovascular · 56d
Cleared Dec 30, 1987
TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE)
K874437
Labeltape Meditect, Inc.
Cardiovascular · 63d
Cleared Dec 29, 1987
FERRIS ECG ELECTRODE W/HYDROGEL
K873682
Ferris Mfg. Corp.
Cardiovascular · 106d
Cleared Dec 07, 1987
RESUBMITTED STANDARD MICROPORE ECG ELECTRODE
K874628
Labeltape Meditect, Inc.
Cardiovascular · 46d
Cleared Nov 23, 1987
ECG ELECTRODE SYSTEM
K873442
Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S
Cardiovascular · 88d
Cleared Oct 16, 1987
NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)
K872871
Labeltape Meditect, Inc.
Cardiovascular · 87d
Cleared Oct 09, 1987
MACTRODE-II
K872784
Marquette Electronics, Inc.
Cardiovascular · 87d
Cleared Aug 03, 1987
ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE
K871441
Nitto Denko America, Inc.
Cardiovascular · 112d
Cleared Jun 10, 1987
BIODAN TYPE COMET ELECTRODE
K871668
National Medical Technology
Cardiovascular · 43d
Cleared Jun 10, 1987
THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE
K871748
The Buddy Systems, Inc.
Cardiovascular · 36d
Cleared Jun 08, 1987
BOWEN REUSEABLE/DISPOSABLE ELECTRODE
K871325
Bowen & Company, Inc.
Cardiovascular · 66d
Cleared Jun 05, 1987
ELECTROTRACE DISP REST EKG ELECTRODE, CAT. ET1200
K871626
Jason Marketing Co.
Cardiovascular · 39d
Cleared May 12, 1987
CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO
K871412
Contour Electrodes, Inc.
Cardiovascular · 34d