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FDA 510(k)

Integrated Catch-up Freedom Syringe Driver Infusion System

K-Number: K162613 · 2017-08-31

ApplicantRepro-Med Systems, Inc. Dba Rms Medical Products
Decision Date2017-08-31
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Integrated Catch-up Freedom Syringe Driver Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Repro-Med Systems, Inc. Dba Rms Medical Products. It received FDA 510(k) clearance on 2017-08-31 under 510(k) 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. The listed applicant is Repro-Med Systems, Inc. Dba Rms Medical Products. The 510(k) number is K162613.

When did Integrated Catch-up Freedom Syringe Driver Infusion System receive FDA 510(k) clearance?

Integrated Catch-up Freedom Syringe Driver Infusion System received FDA 510(k) clearance on 2017-08-31, under 510(k) number K162613.

Who is the listed applicant for Integrated Catch-up Freedom Syringe Driver Infusion System?

The FDA 510(k) record lists Repro-Med Systems, Inc. Dba Rms Medical Products as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07721350Prospective Evaluation of Subcutaneous Administration of Daratumumab by the FreedomEDGE® Infusion SystemNOT_YET_RECRUITING

Other records listing Repro-Med Systems, Inc. Dba Rms Medical Products as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

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.

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