EpiMonitor is an AI-enabled medical device from Empatica Srl, listed by FDA (510(k), K250515) with a decision date of 2025-06-19. Review panel: Neurology.
| FDA submission number | K250515 |
|---|---|
| Pathway | 510(k) |
| Company | Empatica Srl |
| Review panel (specialty) | Neurology |
| FDA decision date | 2025-06-19 |
| Decision | Substantially Equivalent |
| Product code | POS |
| Classification | Physiological Signal Based Seizure Monitoring System |
| Device class | 2 |
| Regulation number | 882.1580 |
| Review time (calendar days) | 118 |
| Applicant country | IT |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.