510(k) K250515
K250515 is an FDA 510(k) premarket notification submitted by Empatica S.r.l. for the device "EpiMonitor". The FDA issued a decision of Substantially Equivalent on June 19, 2025. The device falls under product code POS (Physiological Signal Based Seizure Monitoring System), a Class II device regulated under 21 CFR 882.1580. Empatica S.r.l. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 2025
- Date Received
- February 21, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Physiological Signal Based Seizure Monitoring System
- Device Class
- Class II
- Regulation Number
- 882.1580
- Review Panel
- NE
- Submission Type
The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device.