Clearance Summary
BELMONT BUDDY FLUID WARMER received FDA 510(k) clearance under submission number K052547, sponsored by Belmont Instrument Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2005-10-13.
- Submission: K052547
- Applicant / Sponsor: Belmont Instrument Corp.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.9205
- Decision date: 2005-10-13
Classification & Regulation
This clearance is catalogued under FDA product code BSB and 21 CFR 864.9205, within the Hematology review panel as a Class II device.