Clearance Summary
ELECTRON WEDGE MODEL MT-EW-1000 received FDA 510(k) clearance under submission number K981992, sponsored by Med-Tec,Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1998-12-15.
- Submission: K981992
- Applicant / Sponsor: Med-Tec,Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5710
- Decision date: 1998-12-15
Classification & Regulation
This clearance is catalogued under FDA product code IXI and 21 CFR 892.5710, within the Radiology review panel as a Class II device.