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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 pediatric autism spectrum disorder diagnosis aid
De Novo Number DEN200069
Device Name Cognoa ASD Diagnosis Aid
Requester
cognoa, inc.
2185 park blvd.
palo alto,  CA  94306
Contact sophie dessalle
Regulation Number882.1491
Classification Product Code
QPF  
Date Received11/03/2020
Decision Date 06/02/2021
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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