Clearance Summary
BMR FACE received FDA 510(k) clearance under submission number K103031, sponsored by Bio-Medical Research, 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 2011-11-10.
- Submission: K103031
- Applicant / Sponsor: Bio-Medical Research, Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2011-11-10
Classification & Regulation
This clearance is catalogued under FDA product code NFO and 21 CFR 882.5890, within the Neurology review panel as a Class II device.