K232107 is an FDA 510(k) clearance for the ?M Warmer System. This device is classified as a Warmer, Thermal, Infusion Fluid (Class II - Special Controls, product code LGZ).
Submitted by Mequ A/S (Kobenhavn N, DK). The FDA issued a Cleared decision on May 31, 2024, 322 days after receiving the submission on July 14, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K232107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2023 |
| Decision Date | May 31, 2024 |
| Days to Decision | 322 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 |