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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automatic Event Detection Software For Polysomnograph With Electroencephalograph
510(k) Number K894155
Device Name SLEEPSCAN
Applicant
Biologic Systems Corp.
One Bio-Logic Plz.
Mudelein,  IL  60060
Applicant Contact GIL RAVIV
Correspondent
Biologic Systems Corp.
One Bio-Logic Plz.
Mudelein,  IL  60060
Correspondent Contact GIL RAVIV
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received06/14/1989
Decision Date 01/26/1990
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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