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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name prognostic assessment software of mild cognitive impairment
De Novo Number DEN220066
Device Name BrainSee
Requester
darmiyan, inc.
1425 berkeley way
berkeley,  CA  94702
Contact kaveh vejdani
Regulation Number882.1454
Classification Product Code
QWT  
Date Received09/29/2022
Decision Date 01/11/2024
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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