The following data is part of a De Novo classification by Cognoa, Inc. with the FDA for Cognoa Asd Diagnosis Aid.
DeNovo ID | DEN200069 |
Device Name: | Cognoa ASD Diagnosis Aid |
Classification | Pediatric Autism Spectrum Disorder Diagnosis Aid |
Applicant | Cognoa, Inc. 2185 Park Blvd. Palo Alto, CA 94306 |
Contact | Sophie Dessalle |
Product Code | QPF |
CFR Regulation Number | 882.1491 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | Device 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 Board | Neurology |
Classification Advisory | Neurology |
Type | Direct |
Date Received | 2020-11-03 |
Decision Date | 2021-06-02 |
Reclassification Order: | Reclassification Order |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860007260605 | DEN200069 | 000 |