Clearance Summary
TECA PREMIERE received FDA 510(k) clearance under submission number K953732, sponsored by Medelec , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1995-10-19.
- Submission: K953732
- Applicant / Sponsor: Medelec , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1900
- Decision date: 1995-10-19
Classification & Regulation
This clearance is catalogued under FDA product code GWJ and 21 CFR 882.1900, within the Neurology review panel as a Class II device.