Clearance Summary
SPEC MODEL M-31 received FDA 510(k) clearance under submission number K090366, sponsored by Source Production & Equipment Co., 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 2009-04-22.
- Submission: K090366
- Applicant / Sponsor: Source Production & Equipment Co., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 2009-04-22
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.