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FDA 510(k)

FREEDOM Integrated Syringe Infusion System

K-Number: K200176 · 2021-12-15

ApplicantRepro-Med Systems, Inc. Dba Koru Medical Systems
Decision Date2021-12-15
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FREEDOM Integrated Syringe Infusion System is a medical device manufactured by Repro-Med Systems, Inc. Dba Koru Medical Systems. It received FDA 510(k) clearance on 2021-12-15 under approval number K200176. 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 FREEDOM Integrated Syringe Infusion System?

FREEDOM Integrated Syringe Infusion System is a medical device that received FDA 510(k) clearance on 2021-12-15. It is manufactured by Repro-Med Systems, Inc. Dba Koru Medical Systems. The 510(k) number is K200176.

When was FREEDOM Integrated Syringe Infusion System approved by the FDA?

FREEDOM Integrated Syringe Infusion System received FDA 510(k) clearance on 2021-12-15, under approval number K200176.

What company makes FREEDOM Integrated Syringe Infusion System?

FREEDOM Integrated Syringe Infusion System is manufactured by Repro-Med Systems, Inc. Dba Koru Medical Systems.

What is the FDA product code for FREEDOM Integrated Syringe Infusion System?

The FDA product code for FREEDOM Integrated Syringe Infusion System is FRN.

Related Clinical Trials

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Related Devices (Code: FRN)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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