POS
10 FDA 510(k) clearances · Product code
189 daysmedian time to decision
829 days90th percentile
10clearances measured
FDA profile
- Official device name
- Physiological Signal Based Seizure Monitoring System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1580
- Medical specialty
- Neurology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Nelli (Version 7.11) (K251506) | Neuro Event Labs OY | 2025-11-21 |
| NightWatch+ US (K243199) | Livassured BV | 2025-07-12 |
| EpiMonitor (K250515) | Empatica S.r.l. | 2025-06-19 |
| EpiWatch Monitoring System (K243515) | Epiwatch, Inc. | 2025-03-07 |
| EpiMonitor (K232915) | Empatica S.r.l. | 2024-02-15 |
| SPEAC System (K200276) | Brain Sentinel, Inc. | 2021-02-06 |
| SPEAC System (K182180) | Brain Sentinel, Inc. | 2019-05-11 |
| Embrace (K181861) | Empatica S.r.l. | 2018-12-20 |
| Embrace (K172935) | Empatica S.r.l. | 2018-01-26 |
| Companion (DEN140033) | Lgch, Inc. | 2017-02-16 |
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Every clearance here is in the API, with alerts when new ones post.