Clearance Summary
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 received FDA 510(k) clearance under submission number K062549, sponsored by Excel Tech. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2006-10-04.
- Submission: K062549
- Applicant / Sponsor: Excel Tech. , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1820
- Decision date: 2006-10-04
Classification & Regulation
This clearance is catalogued under FDA product code ETN and 21 CFR 874.1820, within the Ear, Nose, Throat review panel as a Class II device.