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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 K874136
Device Name PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL
Applicant
Bio-Logic Systems Corp.
One Bio-Logic Plz.
Mudelein,  IL  60060
Applicant Contact THOMAS NALL
Correspondent
Bio-Logic Systems Corp.
One Bio-Logic Plz.
Mudelein,  IL  60060
Correspondent Contact THOMAS NALL
Regulation Number882.1890
Classification Product Code
GWE  
Date Received10/13/1987
Decision Date 03/25/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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