510(k) K260988

°M Warmer System with °M Station by Mequ A/S — Product Code LGZ

K260988 is an FDA 510(k) premarket notification submitted by Mequ A/S for the device "°M Warmer System with °M Station". The FDA issued a decision of Substantially Equivalent on April 24, 2026. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. Mequ A/S has at least 1 other 510(k) clearance on record.