Clearance Summary
BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR received FDA 510(k) clearance under submission number K883092, 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 1988-10-13.
- Submission: K883092
- Applicant / Sponsor: Bennett X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 1988-10-13
Classification & Regulation
This clearance is catalogued under FDA product code IZL and 21 CFR 892.1720, within the Radiology review panel as a Class II device.