Clearance Summary
OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 received FDA 510(k) clearance under submission number K913121, sponsored by Continental 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 1991-08-16.
- Submission: K913121
- Applicant / Sponsor: Continental X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1991-08-16
Classification & Regulation
This clearance is catalogued under FDA product code KXJ and 21 CFR 892.1980, within the Radiology review panel as a Class II device.