K232107
- 510(k) number
- K232107
- Device name
- °M Warmer System
- Applicant
- Mequ A/S DK
- Product code
- LGZ — Warmer, Thermal, Infusion Fluid
- Decision date
- 2024-05-31
- Date received
- 2023-07-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232107.pdf
Official FDA record: K232107
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.