510(k) DEN200069
DEN200069 is an FDA 510(k) premarket notification submitted by Cognoa, Inc. for the device "Cognoa ASD Diagnosis Aid". The FDA issued a decision of De Novo Granted on Jun 2, 2021. The device falls under product code QPF (Pediatric Autism Spectrum Disorder Diagnosis Aid), a Class II device regulated under 21 CFR 882.1491. Cognoa, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Jun 2, 2021
- Date Received
- Nov 3, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pediatric Autism Spectrum Disorder Diagnosis Aid
- Device Class
- Class II
- Regulation Number
- 882.1491
- Review Panel
- NE
- Submission Type
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.