Clearance Summary
Sleep Watch received FDA 510(k) clearance under submission number K251574, sponsored by Ambulatory Monitoring, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-07-31.
- Submission: K251574
- Applicant / Sponsor: Ambulatory Monitoring, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 2025-07-31
Classification & Regulation
This clearance is catalogued under FDA product code LEL and 21 CFR 882.5050, within the Neurology review panel as a Class II device.