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
97–120 of 329
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
Cleared Dec 13, 1989
RED DOT CARDIAC SENSOR SYSTEM
K896155
3M Company
Cardiovascular · 50d
Cleared Nov 03, 1989
BABY MAC ELECTROCARDIOGRAPH ELECTRODE
K895834
Marquette Electronics, Inc.
Cardiovascular · 32d
Cleared Oct 26, 1989
ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO.
K894991
Labeltape Meditect, Inc.
Cardiovascular · 79d
Cleared Oct 12, 1989
CARE DISP. DIAG. ELECTRODES, SILVER/SILVER
K894462
Labeltape Meditect, Inc.
Cardiovascular · 86d
Cleared Oct 03, 1989
SELECTRODE
K894920
S & W Medico Teknik
Cardiovascular · 62d
Cleared Jul 14, 1989
VITATRACE
K893425
Lectec Corp.
Cardiovascular · 73d
Cleared May 01, 1989
F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM
K884980
S & W Medico Teknik
Cardiovascular · 153d
Cleared Mar 22, 1989
BARD NEONATAL ECG MONITORING ELECTRODE
K891075
C.R. Bard, Inc.
Cardiovascular · 21d
Cleared Mar 15, 1989
RADIOLUCENT ECG ELECTRODE MODEL NO: 1680
K890201
Medtronic Vascular
Cardiovascular · 57d
Cleared Mar 10, 1989
F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM
K884981
S & W Medico Teknik
Cardiovascular · 101d
Cleared Mar 10, 1989
M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68
K884982
S & W Medico Teknik
Cardiovascular · 101d
Cleared Mar 09, 1989
M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55
K884983
S & W Medico Teknik
Cardiovascular · 100d
Cleared Mar 09, 1989
M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40
K884984
S & W Medico Teknik
Cardiovascular · 100d
Cleared Jan 25, 1989
POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES
K885262
Valleylab, Inc.
Cardiovascular · 33d
Cleared Jan 24, 1989
BARD TAB ECG MONITORING ELECTRODE
K890103
C.R. Bard, Inc.
Cardiovascular · 14d
Cleared Oct 06, 1988
BARD MULTI-TAC ECG MONITORING ELECTRODE
K884064
C.R. Bard, Inc.
Cardiovascular · 10d
Cleared Jul 20, 1988
SYNCOR (R) MODEL S-801 ECG ELECTRODE
K882216
Lectec Corp.
Cardiovascular · 55d
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