Clearance Summary
TREZ_HD received FDA 510(k) clearance under submission number K131266, 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 2014-02-14.
- Submission: K131266
- Applicant / Sponsor: Excel-Tech Ltd. (Xltek)
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2014-02-14
Classification & Regulation
This clearance is catalogued under FDA product code GWQ and 21 CFR 882.1400, within the Neurology review panel as a Class II device.