510(k) K243515
- Device
- EpiWatch Monitoring System
- Applicant
- Epiwatch, Inc.
- 510(k) number
- K243515
- Product code
- POS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-07
- Date received
- 2024-11-13
- Regulation
- 882.1580
- Classification name
- Physiological Signal Based Seizure Monitoring System
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Teresa Prego
- Address
- C/O Johns Hopkins Technology Ventures 1812 Ashland Ave., Suite 110 Baltimore MD US 21205 21205
FDA Registration Numbers#
- 3043349255
- 3022175264
- 3012933969
- 3014886121
- 3017084392
- 3042639792
Source Documents#
Other 510(k) Records For Product Code POS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251506 | Nelli (Version 7.11) | Neuro Event Labs OY | 2025-11-21 |
| K243199 | NightWatch+ US | Livassured BV | 2025-07-12 |
| K250515 | EpiMonitor | Empatica S.r.l. | 2025-06-19 |
| K232915 | EpiMonitor | Empatica S.r.l. | 2024-02-15 |
| K200276 | SPEAC System | Brain Sentinel, Inc. | 2021-02-06 |
| K182180 | SPEAC System | Brain Sentinel, Inc. | 2019-05-11 |
| K181861 | Embrace | Empatica S.r.l. | 2018-12-20 |
| K172935 | Embrace | Empatica S.r.l. | 2018-01-26 |
| DEN140033 | Companion | Lgch, Inc. | 2017-02-16 |