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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conditioner, Signal, Physiological
510(k) Number K872290
Device Name BIO-LOGIC BANKER
Applicant
Bio-Logic Systems Corp.
One Bio-Logic Plz.
Mudelein,  IL  60060
Applicant Contact KAMM, P.E.
Correspondent
Bio-Logic Systems Corp.
One Bio-Logic Plz.
Mudelein,  IL  60060
Correspondent Contact KAMM, P.E.
Regulation Number882.1845
Classification Product Code
GWK  
Date Received06/16/1987
Decision Date 10/06/1987
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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