Clearance Summary
X-RAY STAND & OPERATING CHAIR received FDA 510(k) clearance under submission number K803162, sponsored by Downs Surgical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1981-01-28.
- Submission: K803162
- Applicant / Sponsor: Downs Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1770
- Decision date: 1981-01-28
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.