FDA Product Code
FDA Product Code POS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1580
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251506 | Nelli (Version 7.11) | Neuro Event Labs OY | 2025-11-21 | Traditional | PDF ↗ |
| K243199 | NightWatch+ US | Livassured BV | 2025-07-12 | Traditional | PDF ↗ |
| K250515 | EpiMonitor | Empatica S.r.l. | 2025-06-19 | Special | PDF ↗ |
| K243515 | EpiWatch Monitoring System | Epiwatch, Inc. | 2025-03-07 | Traditional | PDF ↗ |
| K232915 | EpiMonitor | Empatica S.r.l. | 2024-02-15 | Traditional | PDF ↗ |
| K200276 | SPEAC System | Brain Sentinel, Inc. | 2021-02-06 | Traditional | PDF ↗ |
| K182180 | SPEAC System | Brain Sentinel, Inc. | 2019-05-11 | Traditional | PDF ↗ |
| K181861 | Embrace | Empatica S.r.l. | 2018-12-20 | Traditional | PDF ↗ |
| K172935 | Embrace | Empatica S.r.l. | 2018-01-26 | Traditional | PDF ↗ |
| DEN140033 | Companion | Lgch, Inc. | 2017-02-16 | Direct | — |
Product code POS · Class II · Neurology. Data: openFDA.