Physiological Signal Based Seizure Monitoring System
Regulation 882.1580
1510(k)s in 12 months (10 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in POS
| Company | 510(k)s | Recalls |
|---|---|---|
| Empatica S.r.l. | 4 | 0 |
| Brain Sentinel, Inc. | 2 | 0 |
| EMPATICA SRL | 0 | 1 |
| Epiwatch, Inc. | 1 | 0 |
| Lgch, Inc. | 1 | 0 |
| Livassured BV | 1 | 0 |
| Neuro Event Labs OY | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 2025 | K251506 | Nelli (Version 7.11) Neuro Event Labs OY, FI | POS |
| Jul 12, 2025 | K243199 | NightWatch+ US Livassured BV, NL | POS |
| Jun 19, 2025 | K250515 | EpiMonitor Empatica S.r.l., IT | POS |
| Mar 7, 2025 | K243515 | EpiWatch Monitoring System Epiwatch, Inc. | POS |
| Feb 15, 2024 | K232915 | EpiMonitor Empatica S.r.l., IT | POS |
| Feb 6, 2021 | K200276 | SPEAC System Brain Sentinel, Inc. | POS |
| May 11, 2019 | K182180 | SPEAC System Brain Sentinel, Inc. | POS |
| Dec 20, 2018 | K181861 | Embrace Empatica S.r.l., IT | POS |
| Jan 26, 2018 | K172935 | Embrace Empatica S.r.l., IT | POS |
| Feb 16, 2017 | DEN140033 | Companion Lgch, Inc. | POS |
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