Clearance Summary
MODEL C2-5000 OVERHEAD TUBE SUPPORT received FDA 510(k) clearance under submission number K873283, 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 1987-09-10.
- Submission: K873283
- Applicant / Sponsor: Transworld X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1770
- Decision date: 1987-09-10
Classification & Regulation
This clearance is catalogued under FDA product code IYB and 21 CFR 892.1770, within the Radiology review panel as a Class I device.