GXY · Class II · 21 CFR 882.1320

FDA Product Code GXY: Electrode, Cutaneous

Leading manufacturers include Medtronic Vascular, Empi and Aspect Medical Systems, Inc..

440
Total
440
Cleared
127d
Avg days
1976
Since
440 devices
289–312 of 440
Cleared May 31, 1979
T.E.N.S.* SINGLE-USE ELECTRODE
K790850
3M Company
Neurology · 27d
Cleared Mar 27, 1979
ELECTRODE, ELECTROFLEX
K790316
Andover Medical, Inc.
Neurology · 40d
Cleared Feb 07, 1979
MEDTRONIC MODEL 3797 ELECTRODE
K782137
Medtronic Vascular
Neurology · 42d
Cleared Oct 31, 1978
EEG LEAD ASSEMBLY
K781494
Graphic Controls Corp.
Neurology · 64d
Cleared Jun 02, 1978
EAR ELECTRODE-ADULT & PEDIATRIC
K780537
Life-Tech Instruments, Inc.
Neurology · 60d
Cleared Sep 20, 1977
KARAYA ELECTRODES
K771719
Lectec Corp.
Neurology · 8d