Integrated Catch-up Freedom Syringe Driver Infusion System
K-Number: K162613 · 2017-08-31
Decision Date2017-08-31
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Integrated Catch-up Freedom Syringe Driver Infusion System is a medical device manufactured by Repro-Med Systems, Inc. Dba Rms Medical Products. It received FDA 510(k) clearance on 2017-08-31 under approval number K162613. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Integrated Catch-up Freedom Syringe Driver Infusion System?
Integrated Catch-up Freedom Syringe Driver Infusion System is a medical device that received FDA 510(k) clearance on 2017-08-31. It is manufactured by Repro-Med Systems, Inc. Dba Rms Medical Products. The 510(k) number is K162613.
When was Integrated Catch-up Freedom Syringe Driver Infusion System approved by the FDA?
Integrated Catch-up Freedom Syringe Driver Infusion System received FDA 510(k) clearance on 2017-08-31, under approval number K162613.
What company makes Integrated Catch-up Freedom Syringe Driver Infusion System?
Integrated Catch-up Freedom Syringe Driver Infusion System is manufactured by Repro-Med Systems, Inc. Dba Rms Medical Products.
What is the FDA product code for Integrated Catch-up Freedom Syringe Driver Infusion System?
The FDA product code for Integrated Catch-up Freedom Syringe Driver Infusion System is FRN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.