DRX · Class II · 21 CFR 870.2360

FDA Product Code DRX: Electrode, Electrocardiograph

Leading manufacturers include Graphic Controls Corp., S & W Medico Teknik and Conmedcorp.

329
Total
329
Cleared
123d
Avg days
1976
Since

FDA 510(k) Cleared Electrode, Electrocardiograph Devices (Product Code DRX)

329 devices
1–24 of 329
Cleared Jun 11, 2010
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
K100129
Ambu A/S
Cardiovascular · 143d
Cleared Aug 07, 2009
CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES
K091856
Conmed Corporation
Cardiovascular · 45d
Cleared Oct 25, 2006
AMBU WHITE SENSOR CFM, CFL
K052944
Ambu A/S
Cardiovascular · 370d
Cleared Oct 25, 2006
AMBU BLUE SENSOR NEO AND NEO X
K053550
Ambu A/S
Cardiovascular · 309d
Cleared Apr 07, 2006
MACTRODE 3
K060661
Ge Medical Systems Information Technologies
Cardiovascular · 25d
Cleared Nov 26, 1999
ECG ELECTRODE (VARIOUS)
K991105
Conmedcorp
Cardiovascular · 239d
Cleared Nov 13, 1998
MEDI-TRACE 4103 NEONATAL ELECTRODE
K981964
Graphic Controls Corp.
Cardiovascular · 162d
Cleared Mar 11, 1997
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM
K963787
Conmedcorp
Cardiovascular · 172d
Cleared Nov 19, 1996
MEDI-TRACE 5700 RESTING ECG ELECTRODE
K963151
Graphic Controls Corp.
Cardiovascular · 102d
Cleared Nov 15, 1996
MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE
K963038
Graphic Controls Corp.
Cardiovascular · 102d
Cleared Oct 28, 1996
MEDI-TRACE 200, MEDI-TRACE 200-30
K960968
Graphic Controls Corp.
Cardiovascular · 231d
Cleared Aug 08, 1996
BODYTRODE
K961288
Marquette Electronics, Inc.
Cardiovascular · 126d
Cleared Jul 11, 1996
QUICKELS QS 200 SYSTEM
K954772
Ferguson Medical
Cardiovascular · 272d
Cleared Jul 11, 1996
QUICKELS QS 100 SYSTEM
K954773
Ferguson Medical
Cardiovascular · 272d
Cleared Jun 07, 1996
MEDI-TRACE RADIOLUCENT
K961395
Graphic Controls Corp.
Cardiovascular · 57d
Cleared May 16, 1996
CONMED ECG/EKG ELECTRODES
K954389
Conmedcorp
Cardiovascular · 240d
Cleared Apr 09, 1996
CONMED EKG STRIPPER
K960264
Conmedcorp
Cardiovascular · 82d
Cleared Feb 06, 1996
CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE
K954388
Conmedcorp
Cardiovascular · 140d
Cleared Jul 07, 1995
MEDI-TRACE(R) 500 ECG ELECTRODE
K945479
Graphic Controls Corp.
Cardiovascular · 241d
Cleared Jul 07, 1995
GRAPHIC CONTROLS PROTRACE ECG ELECTRODE
K950485
Graphic Controls Corp.
Cardiovascular · 151d
Cleared Jul 03, 1995
GRAPHIC CONTROLS BIOTAC ECO ELECTRODE
K950488
Graphic Controls Corp.
Cardiovascular · 147d
Cleared Jul 03, 1995
GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE
K950489
Graphic Controls Corp.
Cardiovascular · 147d
Cleared May 17, 1995
GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE
K950486
Graphic Controls Corp.
Cardiovascular · 100d
Cleared May 17, 1995
GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE
K950487
Graphic Controls Corp.
Cardiovascular · 100d

About Product Code DRX - Regulatory Context