Clearance Summary
SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 received FDA 510(k) clearance under submission number K021360, 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 2003-06-10.
- Submission: K021360
- Applicant / Sponsor: Med-Tec,Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 2003-06-10
Classification & Regulation
This clearance is catalogued under FDA product code KXK and 21 CFR 892.5730, within the Radiology review panel as a Class II device.