Clearance Summary
QiF Blood and Fluid Warmer received FDA 510(k) clearance under submission number K163708, sponsored by Quality IN Flow , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2017-04-20.
- Submission: K163708
- Applicant / Sponsor: Quality IN Flow , Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2017-04-20
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.