Clearance Summary
NightWatch+ US received FDA 510(k) clearance under submission number K243199, sponsored by Livassured BV. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-07-12.
- Submission: K243199
- Applicant / Sponsor: Livassured BV
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1580
- Decision date: 2025-07-12
Classification & Regulation
This clearance is catalogued under FDA product code POS and 21 CFR 882.1580, within the Neurology review panel as a Class II device.