510(k) K213191

S-Line by Barkey GmbH & Co. KG — Product Code LGZ

K213191 is an FDA 510(k) premarket notification submitted by Barkey GmbH & Co. KG for the device "S-Line". The FDA issued a decision of Substantially Equivalent on May 24, 2022. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. Barkey GmbH & Co. KG has at least 1 other 510(k) clearance on record.