510(k) K250515 ยท POS Physiological Signal Based Seizure Monitoring System
EpiMonitor
| Applicant | Empatica S.r.l., Milano, IT |
| Decision | Substantially Equivalent, Jun 19, 2025 |
| Received | Feb 21, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250515
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.