K192325 is an FDA 510(k) clearance for the Quantum Blood and Fluid Warming System. This device is classified as a Warmer, Thermal, Infusion Fluid (Class II - Special Controls, product code LGZ).
Submitted by Life Warmer, Inc. (Addison, US). The FDA issued a Cleared decision on October 18, 2019, 52 days after receiving the submission on August 27, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K192325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2019 |
| Decision Date | October 18, 2019 |
| Days to Decision | 52 days |
| Submission Type | Special |
| 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 |