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
289–312 of 329
Cleared Nov 02, 1981
THE NEW 1600 ELECTRODE
K812878
Andover Medical, Inc.
Cardiovascular · 19d
Cleared Sep 25, 1981
DISPOSABLE ELECTRODE, #1610
K812276
Andover Medical, Inc.
Cardiovascular · 43d
Cleared May 13, 1981
ESOPHAGEAL PILL ELECTRODE
K810895
Con Med Equipment, Inc.
Cardiovascular · 40d
Cleared Mar 17, 1981
QUINTON LTE ELECTRODE
K810563
Quinton, Inc.
Cardiovascular · 14d
Cleared Mar 11, 1981
DISPOSABLE ELECTRODE FOR EKG
K803179
Midwest Monitoring
Cardiovascular · 85d
Cleared Jan 29, 1981
INFANT ECG ELECTRODE #60-1029
K810102
Aspen Laboratories, Inc.
Cardiovascular · 13d
Cleared Jan 29, 1981
ADULT ECG ELECTRODE #60-0724
K810103
Aspen Laboratories, Inc.
Cardiovascular · 13d
Cleared Sep 09, 1980
ELECTROCARDIOGRAPH ELECTRODE
K801846
Phoenix Glove Co.
Cardiovascular · 36d
Cleared Feb 22, 1980
VXTRA BACK PACK EKG ELECTRODE CAT. NO.
K792436
Vxtra Corp.
Cardiovascular · 86d
Cleared Nov 13, 1979
BARD BIOMEDICAL PRINTED SILVER ELECTRODE
K792040
C.R. Bard, Inc.
Cardiovascular · 32d
Cleared Jul 10, 1979
PREGELLED DISPOSABLE ECG ELECTRODES
K791139
Hayes Products, Inc.
Cardiovascular · 22d
Cleared Jul 10, 1979
PREGELLED DISPOSABLE EELCTRO. SERIES 600
K791140
Hayes Products, Inc.
Cardiovascular · 22d
Cleared Jun 11, 1979
SMART BILECTRODES
K791006
Electronics For Medicine, Inc.
Cardiovascular · 11d
Cleared Jun 01, 1979
ECG ELECTRODES, PEDIATRIC-FOAM TAPE
K791002
Physio-Control Corp.
Cardiovascular · 3d
Cleared Jun 01, 1979
ECG ELECTRODES, PEDIATRIC-MICROPOROUS TA
K791003
Physio-Control Corp.
Cardiovascular · 3d
Cleared May 31, 1979
LIFEPATCH ECG ELECTRODES
K790959
Physio-Control Corp.
Cardiovascular · 9d
Cleared May 18, 1979
800 ECG ELECTRODE
K790507
Simonsen & Weels Eftf.
Cardiovascular · 66d
Cleared Apr 26, 1979
NDM PAPER TAPE ECG ELECTRODE
K790730
Ndm Corp.
Cardiovascular · 13d
Cleared Apr 03, 1979
ELECTRODES, FERRIS ECG, TYPES 905,906
K790305
Ferris Mfg. Corp.
Cardiovascular · 49d
Cleared Feb 01, 1979
ELECTRODE SYSTEM, QUIK-PREP
K782079
Quinton, Inc.
Cardiovascular · 50d
Cleared Dec 19, 1978
ELECTRODES, OFFSET AND DX
K781963
Graphic Controls Corp.
Cardiovascular · 27d
Cleared Nov 29, 1978
EKG ELECTRODES, DISPOSABLE
K781940
Hayes Products, Inc.
Cardiovascular · 9d
Cleared Oct 31, 1978
PREGELLED DISPOSABLE E.K.G. ELECTRODE
K781430
Vermont Medical, Inc.
Cardiovascular · 71d
Cleared Oct 17, 1978
ECG ELECTRODE, 2021, 2022, 2032, 2033
K781514
Cardio-Dynamics Laboratories, Inc.
Cardiovascular · 46d