Clearance Summary
HOTLINE FLUID WARMER received FDA 510(k) clearance under submission number K911383, sponsored by Level 1 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 1991-10-17.
- Submission: K911383
- Applicant / Sponsor: Level 1 Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1991-10-17
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.