Clearance Summary
THE BELMONT BUDDY LITE FLUID WARMER received FDA 510(k) clearance under submission number K112639, 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 2011-11-16.
- Submission: K112639
- Applicant / Sponsor: Belmont Instrument Corp.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.9205
- Decision date: 2011-11-16
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.