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 |