Cognoa ASD Diagnosis Aid

Pediatric Autism Spectrum Disorder Diagnosis Aid

Cognoa, Inc.

The following data is part of a De Novo classification by Cognoa, Inc. with the FDA for Cognoa Asd Diagnosis Aid.

Pre-market Notification Details

DeNovo IDDEN200069
Device Name:Cognoa ASD Diagnosis Aid
ClassificationPediatric Autism Spectrum Disorder Diagnosis Aid
Applicant Cognoa, Inc. 2185 Park Blvd. Palo Alto,  CA  94306
ContactSophie Dessalle
Product CodeQPF  
CFR Regulation Number882.1491 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardNeurology
Classification AdvisoryNeurology
TypeDirect
Date Received2020-11-03
Decision Date2021-06-02
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860007260605 DEN200069 000

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