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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 K933233
Device Name CEEGRAPH, MODIFICATION
Applicant
Bio-Logic Systems Corp.
One Bio-Logic Plaza
Mundelein,  IL  60060 -3700
Applicant Contact CATHY BUHNER
Correspondent
Bio-Logic Systems Corp.
One Bio-Logic Plaza
Mundelein,  IL  60060 -3700
Correspondent Contact CATHY BUHNER
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received04/21/1993
Decision Date 03/03/1994
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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