510(k) K162613

Integrated Catch-up Freedom Syringe Driver Infusion System by Repro-Med Systems, Inc. Dba Rms Medical Products — Product Code FRN

K162613 is an FDA 510(k) premarket notification submitted by Repro-Med Systems, Inc. Dba Rms Medical Products for the device "Integrated Catch-up Freedom Syringe Driver Infusion System". The FDA issued a decision of Substantially Equivalent on Aug 31, 2017. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Repro-Med Systems, Inc. Dba Rms Medical Products has 2 other 510(k) clearances on record.