Clearance Summary
OLYMPIC BRAINZ MONITOR received FDA 510(k) clearance under submission number K123079, sponsored by Excel-Tech Ltd. (Xltek). The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2013-05-08.
- Submission: K123079
- Applicant / Sponsor: Excel-Tech Ltd. (Xltek)
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2013-05-08
Classification & Regulation
This clearance is catalogued under FDA product code OMA and 21 CFR 882.1400, within the Neurology review panel as a Class II device.