Clearance Summary
BAIR HUGGER BLOOD/FLUID WARMER received FDA 510(k) clearance under submission number K973741, sponsored by Augustine Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1998-04-30.
- Submission: K973741
- Applicant / Sponsor: Augustine Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.9205
- Decision date: 1998-04-30
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.