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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 Full-Montage Electroencephalograph
510(k) Number K951594
Device Name BIO-LOGIC AUTOMATIC EVENT ANALYSIS
Applicant
Bio-Logic Systems Corp.
One Bio-Logic Plaza
Mundelein,  IL  60060 -3700
Applicant Contact NORMAN E BRUNNER
Correspondent
Bio-Logic Systems Corp.
One Bio-Logic Plaza
Mundelein,  IL  60060 -3700
Correspondent Contact NORMAN E BRUNNER
Regulation Number882.1400
Classification Product Code
OMB  
Date Received04/06/1995
Decision Date 08/22/1995
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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