Name: Predicase
Price: 199 USD

K-number	K211206
Device name	FreedomEdge(R) Syringe Infusion System
Applicant	Repro-Medical System, Inc., Dba Koru Medical Systems
Product code	FRN
Device class	Class II
Decision date	Nov 9, 2021
Decision	Substantially Equivalent
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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FreedomEdge(R) Syringe Infusion System

Everything you need for a 510(k) submission. Nothing you don't.