Clearance Summary
BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE received FDA 510(k) clearance under submission number K913243, sponsored by Bennett 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 1991-09-19.
- Submission: K913243
- Applicant / Sponsor: Bennett X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1950
- Decision date: 1991-09-19
Classification & Regulation
This clearance is catalogued under FDA product code IXG and 21 CFR 892.1950, within the Radiology review panel as a Class I device.