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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 K870450
Device Name SZAC-16 SEIZURE ANALYSIS COMPUTER
Applicant
Grass-Telefactor Product Group
Union Hill Bldg., Dehaven St.
W. Conshohocken,  PA  19428
Applicant Contact JOHN B CHATTEN
Correspondent
Grass-Telefactor Product Group
Union Hill Bldg., Dehaven St.
W. Conshohocken,  PA  19428
Correspondent Contact JOHN B CHATTEN
Regulation Number882.1400
Classification Product Code
OMB  
Date Received02/03/1987
Decision Date 04/08/1987
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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