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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Photic, Evoked Response
510(k) Number K810481
Device Name VISUAL PATTERN REVERSAL GEN. & PHOTIC S.
Applicant
AMPLAID USA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMPLAID USA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1890
Classification Product Code
GWE  
Date Received02/23/1981
Decision Date 03/11/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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