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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K983913
Device Name MODIFICATION TO BIO-LOGIC SLEEPSCAN
Applicant
Bio-Logic Systems Corp.
One Bio-Logic Plz.
Mudelein,  IL  60060
Applicant Contact NORMAN E BRUNNER
Correspondent
Bio-Logic Systems Corp.
One Bio-Logic Plz.
Mudelein,  IL  60060
Correspondent Contact NORMAN E BRUNNER
Regulation Number882.1400
Classification Product Code
OLV  
Date Received11/04/1998
Decision Date 11/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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