POS
- Product code
- POS
- Device name
- Physiological Signal Based Seizure Monitoring System
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1580
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 10 (all years; only the last 3 years are listed here)
FDA classification definition
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.
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251506 | 2025-11-21 | Neuro Event Labs OY | Nelli (Version 7.11) | |
| K243199 | 2025-07-12 | Livassured BV | NightWatch+ US | |
| K250515 | 2025-06-19 | Empatica S.r.l. | EpiMonitor | |
| K243515 | 2025-03-07 | Epiwatch, Inc. | EpiWatch Monitoring System | |
| K232915 | 2024-02-15 | Empatica S.r.l. | EpiMonitor |
Official FDA classification page: POS
Classification and pathway per current FDA publications. Data from openFDA (CC0).