FreedomEdge Syringe Infusion System

Pump, Infusion

Repro-Medical System, Inc., Dba Koru Medical Systems

The following data is part of a premarket notification filed by Repro-medical System, Inc., Dba Koru Medical Systems with the FDA for Freedomedge Syringe Infusion System.

Pre-market Notification Details

Device IDK214045
510k NumberK214045
Device Name:FreedomEdge Syringe Infusion System
ClassificationPump, Infusion
Applicant Repro-Medical System, Inc., Dba Koru Medical Systems 24 Carpenter Road Chester,  NY  10918
ContactChristopher Pazdan
CorrespondentKachi Enyinna
510K Technology Group LLC 17 Orchard Terrace East Arlington,  MA  02474
Product CodeFRN  
Subsequent Product CodeFPA
Subsequent Product CodePKP
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-27
Decision Date2022-04-29

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