K250515
- 510(k) number
- K250515
- Device name
- EpiMonitor
- Applicant
- Empatica S.r.l. IT
- Product code
- POS — Physiological Signal Based Seizure Monitoring System
- Decision date
- 2025-06-19
- Date received
- 2025-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250515.pdf
Official FDA record: K250515
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.