Clearance Summary
MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES received FDA 510(k) clearance under submission number K071782, sponsored by Micromed S.P.A.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2008-01-10.
- Submission: K071782
- Applicant / Sponsor: Micromed S.P.A.
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2008-01-10
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.