GWJ · Class II · 21 CFR 882.1900

FDA Product Code GWJ: Stimulator, Auditory, Evoked Response

Leading manufacturers include Bio-Logic Systems Corp., Intelligent Hearing Systems and Path Medical GmbH.

76
Total
76
Cleared
114d
Avg days
1977
Since
76 devices
49–72 of 76
Cleared Sep 17, 1986
40-HZ AUDITORY EVOKED RESPONSE TEST
K862361
Cadwell Laboratories, Inc.
Neurology · 86d
Cleared Sep 17, 1986
INSERT EARPHONES
K862363
Cadwell Laboratories, Inc.
Neurology · 86d
Cleared Mar 08, 1983
MULTI-SIGNAL AUDITORY STIMULATOR SM700
K830579
Nicolet Biomedical Instruments
Neurology · 13d
Cleared Aug 25, 1982
AUDIOMETERS (VARIOUS MODELS)
K822177
Kelleher Corp.
Neurology · 33d
Cleared Dec 14, 1981
TECA VISUAL/AUDIO STIMULATOR MODEL CS-2
K813009
Teca, Inc.
Neurology · 48d
Cleared Apr 21, 1978
ELECTRIC RESPONSE AUDIOMETER
K780540
Life-Tech Instruments, Inc.
Neurology · 18d
Cleared Feb 28, 1977
SYS. FOR REC. BSER RESPONSES
K770268
Life-Tech Instruments, Inc.
Neurology · 17d