Clearance Summary
SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER received FDA 510(k) clearance under submission number K060851, sponsored by The Smithworks Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2006-12-22.
- Submission: K060851
- Applicant / Sponsor: The Smithworks Company
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2006-12-22
Classification & Regulation
This clearance is catalogued under FDA product code LGZ and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.