GWE · Class II · 21 CFR 882.1890

FDA Product Code GWE: Stimulator, Photic, Evoked Response

Leading manufacturers include Teca, Inc., Bio-Logic Systems Corp. and Nihon Kohden America, Inc..

49
Total
49
Cleared
178d
Avg days
1978
Since
49 devices
25–48 of 49
Cleared Feb 25, 1985
VPS 2250, CSU2250 & VFU 2250
K844659
Madsen Electronics (Canada) , Ltd.
Neurology · 91d
Cleared Nov 09, 1984
SLS 3500 LED VISUAL STIMULATOR
K842381
Nihon Kohden America, Inc.
Neurology · 144d
Cleared Aug 08, 1984
LED STIMULATOR LS-05
K834442
Teca, Inc.
Neurology · 236d
Cleared May 13, 1983
BIOLOGIC SYSTEM BL 101
K831047
Bio-Logic Systems Corp.
Neurology · 43d
Cleared Sep 17, 1979
STIMULATOR MODEL SSS-1101
K791149
Nihon Kohden America, Inc.
Neurology · 94d
Cleared May 23, 1979
STIMULATOR, NIC-106 VISUAL
K790570
Nicolet Biomedical Instruments
Neurology · 61d
Cleared Nov 08, 1978
MODEL 7320 VISUAL STIMULATOR
K781461
Life-Tech Instruments, Inc.
Neurology · 82d
Cleared Aug 23, 1978
TECA VS6 VIDEO STIMULATOR
K781398
Teca, Inc.
Neurology · 8d