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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 K842784
Device Name CEREGROTRAC
Applicant
Advanced Instruments, Inc.
Shorashim
Applicant Contact PHYLLIS BELLIN
Correspondent
Advanced Instruments, Inc.
Shorashim
Correspondent Contact PHYLLIS BELLIN
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received07/17/1984
Decision Date 01/10/1985
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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