POS — Physiological Signal Based Seizure Monitoring System Class II
Classification Details
- Product Code
- POS
- Device Class
- Class II
- Regulation Number
- 882.1580
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251506 | neuro event labs | Nelli (Version 7.11) | November 21, 2025 |
| K243199 | livassured | NightWatch+ US | July 12, 2025 |
| K250515 | empatica | EpiMonitor | June 19, 2025 |
| K243515 | epiwatch | EpiWatch Monitoring System | March 7, 2025 |
| K232915 | empatica | EpiMonitor | February 15, 2024 |
| K200276 | brain sentinel | SPEAC System | February 6, 2021 |
| K182180 | brain sentinel | SPEAC System | May 11, 2019 |
| K181861 | empatica | Embrace | December 20, 2018 |
| K172935 | empatica | Embrace | January 26, 2018 |
| DEN140033 | lgch | Companion | February 16, 2017 |