Clearance Summary
Cerebra Sleep System received FDA 510(k) clearance under submission number K213007, sponsored by Cerebra Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2022-07-06.
- Submission: K213007
- Applicant / Sponsor: Cerebra Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2022-07-06
Classification & Regulation
This clearance is catalogued under FDA product code OLV and 21 CFR 882.1400, within the Neurology review panel as a Class II device.