K232915
- 510(k) number
- K232915
- Device name
- EpiMonitor
- Applicant
- Empatica S.r.l. IT
- Product code
- POS — Physiological Signal Based Seizure Monitoring System
- Decision date
- 2024-02-15
- Date received
- 2023-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232915.pdf
Official FDA record: K232915
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.