Clearance Summary
HOT SHOT FLUID WARMER IV FLUIDS received FDA 510(k) clearance under submission number K992258, sponsored by Infra-Med Technologies, Inc.. 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 2000-01-12.
- Submission: K992258
- Applicant / Sponsor: Infra-Med Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 2000-01-12
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.