Clearance Summary
XLTEK SLEEP SYSTEM received FDA 510(k) clearance under submission number K022037, 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 2002-09-10.
- Submission: K022037
- Applicant / Sponsor: Excel Tech. , Ltd.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2002-09-10
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.