510(k) clearance
Neurora
- 510(k) number
- K260064
- Applicant
- Argus Cognitive, Inc.
- Decision date
- Oct 2, 2026
- Date received
- Jan 9, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QPF
- Device type
- Pediatric Autism Spectrum Disorder Diagnosis Aid
- Device class
- Class II
- Regulation
- 21 CFR 882.1491
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Hanover, NH, US