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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K863783
Device Name HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM
Applicant
Hzi Research Center
150 White Plains Rd.
Tarrytown,  NY  10591
Applicant Contact TURAN M ITIL
Correspondent
Hzi Research Center
150 White Plains Rd.
Tarrytown,  NY  10591
Correspondent Contact TURAN M ITIL
Regulation Number882.1400
Classification Product Code
OLT  
Date Received09/26/1986
Decision Date 03/03/1987
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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