FREEDOM Integrated Syringe Infusion System

Pump, Infusion

Repro-Med Systems, Inc., Dba KORU Medical Systems

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

Pre-market Notification Details

Device IDK200176
510k NumberK200176
Device Name:FREEDOM Integrated Syringe Infusion System
ClassificationPump, Infusion
Applicant Repro-Med Systems, Inc., Dba KORU Medical Systems 24 Carpenter Road Chester,  NY  10918
ContactCynthia Lacatena
CorrespondentKachi Enyinna
Repro-Med Systems, Inc., Dba KORU Medical Systems 24 Carpenter Road Chester,  NY  10918
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-24
Decision Date2021-12-15

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