Clearance Summary
MAM-CP X-RAY APPARATUS received FDA 510(k) clearance under submission number K872980, sponsored by Transworld X-Ray Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1987-08-27.
- Submission: K872980
- Applicant / Sponsor: Transworld X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1710
- Decision date: 1987-08-27
Classification & Regulation
This clearance is catalogued under FDA product code IZH and 21 CFR 892.1710, within the Radiology review panel as a Class II device.