K-number	K214045
Device name	FreedomEdge Syringe Infusion System
Applicant	Repro-Medical System, Inc., Dba Koru Medical Systems
Product code	FRN
Device class	Class II
Decision date	Apr 29, 2022
Decision	Substantially Equivalent
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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FreedomEdge Syringe Infusion System

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