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FDA 510(k)

自由整合針筒輸液系統

K 號：K200176 · 2021-12-15

申請人Repro-Med Systems, Inc. Dba Koru Medical Systems
決定日期2021-12-15
產品代碼FRN
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

FREEDOM Integrated Syringe Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Repro-Med Systems, Inc. Dba Koru Medical Systems. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K200176. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

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. The listed applicant is Repro-Med Systems, Inc. Dba Koru Medical Systems. The 510(k) number is K200176.

When did FREEDOM Integrated Syringe Infusion System receive FDA 510(k) clearance?

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

Who is the listed applicant for FREEDOM Integrated Syringe Infusion System?

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

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

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

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