K181775 is an FDA 510(k) clearance for the Quantum Blood and IV Fluid Infusion Warmer. This device is classified as a Warmer, Thermal, Infusion Fluid (Class II - Special Controls, product code LGZ).
Submitted by Life Warmer, Inc. (Plano, US). The FDA issued a Cleared decision on January 28, 2019, 209 days after receiving the submission on July 3, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K181775 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2018 |
| Decision Date | January 28, 2019 |
| Days to Decision | 209 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 |