Cognoa ASD Diagnosis Aid is an AI-enabled medical device from Cognoa, Inc., listed by FDA (De Novo, DEN200069) with a decision date of 2021-06-02. Review panel: Neurology.
| FDA submission number | DEN200069 |
|---|---|
| Pathway | De Novo |
| Company | Cognoa, Inc. |
| Review panel (specialty) | Neurology |
| FDA decision date | 2021-06-02 |
| Decision | Unknown |
| Product code | QPF |
| Classification | Pediatric Autism Spectrum Disorder Diagnosis Aid |
| Device class | 2 |
| Regulation number | 882.1491 |
| Review time (calendar days) | 211 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.