K260988
- 510(k) number
- K260988
- Device name
- °M Warmer System with °M Station
- Applicant
- Mequ A/S DK
- Product code
- LGZ — Warmer, Thermal, Infusion Fluid
- Decision date
- 2026-04-24
- Date received
- 2026-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K260988.pdf
Official FDA record: K260988
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.