510(k) K153760

Volumetric Infusion Controller by DEKA Research & Development — Product Code LDR

K153760 is an FDA 510(k) premarket notification submitted by DEKA Research & Development for the device "Volumetric Infusion Controller". The FDA issued a decision of Substantially Equivalent on October 3, 2016. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725. DEKA Research & Development has at least 10 other 510(k) clearances on record.