510(k) K211618

Fluido Compact Blood and Fluid Warming System by The Surgical Company International B.V. — Product Code LGZ

K211618 is an FDA 510(k) premarket notification submitted by The Surgical Company International B.V. for the device "Fluido Compact Blood and Fluid Warming System". The FDA issued a decision of Substantially Equivalent on June 5, 2023. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. The Surgical Company International B.V. has at least 2 other 510(k) clearances on record.