FDA Product Code
FDA Product Code QPF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1491
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260064 | Neurora | Argus Cognitive, Inc. | 2026-10-02 | Traditional | PDF ↗ |
| K253442 | EarliPoint Assessment | Earlitec Diagnostics | 2026-03-05 | Traditional | PDF ↗ |
| K243558 | Canvas Dx | Cognoa, Inc. | 2025-04-11 | Traditional | PDF ↗ |
| K243891 | EarliPoint System | Earlitec Diagnostics | 2025-03-26 | Special | PDF ↗ |
| K230337 | EarliPoint | Earlitec Diagnostics, Inc. | 2023-06-29 | Traditional | PDF ↗ |
| K213882 | EarliPoint System | Earlitec Diagnostics, Inc. | 2022-06-08 | Traditional | PDF ↗ |
| DEN200069 | Cognoa ASD Diagnosis Aid | Cognoa, Inc. | 2021-06-02 | Direct | — |
Product code QPF · Class II · Neurology. Data: openFDA.