DEN200069 is an FDA 510(k) submission for the Cognoa ASD Diagnosis Aid. This device is classified as a Pediatric Autism Spectrum Disorder Diagnosis Aid (Class II - Special Controls, product code QPF).
Submitted by Cognoa, Inc. (Palo Alto, US). The FDA issued a Not Cleared (DENG) decision on June 2, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1491. A Pediatric Autism Spectrum Disorder Diagnosis Aid Is A Prescription Device That Is Intended For Use As An Aid In The Diagnosis Of Autism Spectrum Disorder In Pediatric Patients..
| 510(k) Number | DEN200069 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | November 03, 2020 |
| Decision Date | June 02, 2021 |
| Days to Decision | 211 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | QPF - Pediatric Autism Spectrum Disorder Diagnosis Aid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1491 |
| Definition | A Pediatric Autism Spectrum Disorder Diagnosis Aid Is A Prescription Device That Is Intended For Use As An Aid In The Diagnosis Of Autism Spectrum Disorder In Pediatric Patients. |