Clearance Summary
XLTEK TREX MODEL#10309 received FDA 510(k) clearance under submission number K042150, sponsored by Excel Tech. , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2004-08-27.
- Submission: K042150
- Applicant / Sponsor: Excel Tech. , Ltd.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2004-08-27
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.