510(k) K183187

nextaro Transfer System, nextaro va by Sfm Medical Devices GmbH — Product Code LHI

K183187 is an FDA 510(k) premarket notification submitted by Sfm Medical Devices GmbH for the device "nextaro Transfer System, nextaro va". The FDA issued a decision of Substantially Equivalent on March 15, 2019. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Sfm Medical Devices GmbH has at least 2 other 510(k) clearances on record.