K243199
- 510(k) number
- K243199
- Device name
- NightWatch+ US
- Applicant
- Livassured BV NL
- Product code
- POS — Physiological Signal Based Seizure Monitoring System
- Decision date
- 2025-07-12
- Date received
- 2024-10-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243199.pdf
Official FDA record: K243199
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.