Clearance Summary
BCM 400CP received FDA 510(k) clearance under submission number K946378, sponsored by B C Medical , 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 1995-05-04.
- Submission: K946378
- Applicant / Sponsor: B C Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1600
- Decision date: 1995-05-04
Classification & Regulation
This clearance is catalogued under FDA product code IZI and 21 CFR 892.1600, within the Radiology review panel as a Class II device.