510(k) K180154
K180154 is an FDA 510(k) premarket notification submitted by Quality IN Flow , Ltd. for the device "QiF Blood and Fluid Warmer". The FDA issued a decision of Substantially Equivalent on April 27, 2018. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. Quality IN Flow , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2018
- Date Received
- January 19, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Warmer, Thermal, Infusion Fluid
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type