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
25–48 of 329
Cleared Apr 07, 2006
MACTRODE 3
K060661
Ge Medical Systems Information Technologies
Cardiovascular · 25d
Cleared Dec 14, 2005
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20
K053011
Bio Protech, Inc.
Cardiovascular · 49d
Cleared Sep 02, 2005
ACCU-LEAD
K050443
Kentec Medical, Inc.
Cardiovascular · 192d
Cleared May 25, 2005
ELECTRODE
K050248
Electramold
Cardiovascular · 111d
Cleared Mar 22, 2005
ACCUHEART ELECTRODE BELT
K043361
Advanced Bioelectric Corporation
Cardiovascular · 105d
Cleared Dec 22, 2004
12-LEAD GLOVE
K033559
Ineedmd
Cardiovascular · 406d
Cleared Sep 22, 2004
AMBU DISPOSABLE ECG ELECTRODE
K041734
Ambu, Inc.
Cardiovascular · 89d
Cleared Sep 15, 2004
DISPOSABLE MONITORING ELECTRODES
K041954
Shanghai Intco Electrode Manufacturing Co., Ltd.
Cardiovascular · 57d
Cleared Jun 28, 2004
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
K041026
Ambu, Inc.
Cardiovascular · 68d
Cleared Apr 07, 2004
PROTAB ECG TABB ELECTRODE
K040784
Bio Protech, Inc.
Cardiovascular · 9d
Cleared Feb 24, 2004
SKINTACT ECG ELECTRODE
K040249
Leonhard Lang GmbH
Cardiovascular · 21d
Cleared Aug 07, 2003
AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)
K030316
Inovise Medical, Inc.
Cardiovascular · 189d
Cleared Jul 10, 2003
BODY SIGNAL ECG ELECTRODE
K031174
Wandy Rubber Industrial Co., Ltd.
Cardiovascular · 87d
Cleared Mar 28, 2003
VERMED A10021 RESTING EKG TAB ELECTRODE
K030073
Vermont Medical, Inc.
Cardiovascular · 79d
Cleared Mar 04, 2003
SKINTACT ECG TAB ELECTRODE
K030509
Leonhard Lang GmbH
Cardiovascular · 13d
Cleared Jan 16, 2003
SKINTACT
K023920
Leonhard Lang GmbH
Cardiovascular · 52d
Cleared Jan 16, 2003
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
K024247
Leonhard Lang GmbH
Cardiovascular · 24d
Cleared Jan 16, 2003
SKINTACT
K024264
Leonhard Lang Co.
Cardiovascular · 24d
Cleared Jan 09, 2003
NIKOMED TRACE 1 ECG ELECTRODES
K022909
Nikomed U.S.A., Inc.
Cardiovascular · 128d
Cleared Nov 14, 2002
SKINTACT ECG ELECTRODE
K023503
Leonhard Lang GmbH
Cardiovascular · 27d
Cleared Nov 07, 2002
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
K020003
Bio Protech, Inc.
Cardiovascular · 309d
Cleared Jun 28, 2002
BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
K020382
Medicotest A/S
Cardiovascular · 143d
Cleared Jan 03, 2002
NEOLEAD
K011564
Neotech Products, Inc.
Cardiovascular · 227d
Cleared Aug 30, 2001
SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
K003804
Niko Medical Products
Cardiovascular · 265d