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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K973883
Device Name BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM
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
GWQ  
Date Received10/14/1997
Decision Date 03/05/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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