510(k) K260064
- Device
- Neurora
- Applicant
- Argus Cognitive, Inc.
- 510(k) number
- K260064
- Product code
- QPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-10-02
- Date received
- 2026-01-09
- Regulation
- 882.1491
- Classification name
- Pediatric Autism Spectrum Disorder Diagnosis Aid
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Andrea Marosan
- Address
- 35 S. Main St. Hanover NH US 03755 03755
FDA Registration Numbers#
- 3027553518
- 3020832299
Source Documents#
Other 510(k) Records For Product Code QPF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253442 | EarliPoint Assessment | Earlitec Diagnostics | 2026-03-05 |
| K243558 | Canvas Dx | Cognoa, Inc. | 2025-04-11 |
| K243891 | EarliPoint System | Earlitec Diagnostics | 2025-03-26 |
| K230337 | EarliPoint | Earlitec Diagnostics, Inc. | 2023-06-29 |
| K213882 | EarliPoint System | Earlitec Diagnostics, Inc. | 2022-06-08 |
| DEN200069 | Cognoa ASD Diagnosis Aid | Cognoa, Inc. | 2021-06-02 |