Nelli (Version 7.11) is an AI-enabled medical device from Neuro Event Labs OY, listed by FDA (510(k), K251506) with a decision date of 2025-11-21. Review panel: Neurology.
| FDA submission number | K251506 |
|---|---|
| Pathway | 510(k) |
| Company | Neuro Event Labs OY |
| Review panel (specialty) | Neurology |
| FDA decision date | 2025-11-21 |
| Decision | Substantially Equivalent |
| Product code | POS |
| Classification | Physiological Signal Based Seizure Monitoring System |
| Device class | 2 |
| Regulation number | 882.1580 |
| Review time (calendar days) | 189 |
| Applicant country | FI |
Official FDA database record · FDA AI-enabled device list
All Neurology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.