K150404 is an FDA 510(k) clearance for the QiF Blood and Fluid Warmer. This device is classified as a Warmer, Thermal, Infusion Fluid (Class II - Special Controls, product code LGZ).
Submitted by Quality IN Flow , Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on June 23, 2016, 491 days after receiving the submission on February 18, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K150404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2015 |
| Decision Date | June 23, 2016 |
| Days to Decision | 491 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LGZ — Warmer, Thermal, Infusion Fluid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |