FDA 510(k)

FreedomEdge(R) 輸液針筒系統

K 號：K211206 · 2021-11-09

申請人Repro-Medical System, Inc., Dba Koru Medical Systems

決定日期2021-11-09

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

FreedomEdge(R) Syringe Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Repro-Medical System, Inc., Dba Koru Medical Systems. It received FDA 510(k) clearance on 2021-11-09 under 510(k) number K211206. 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 FreedomEdge(R) Syringe Infusion System?

FreedomEdge(R) Syringe Infusion System is a medical device that received FDA 510(k) clearance on 2021-11-09. The listed applicant is Repro-Medical System, Inc., Dba Koru Medical Systems. The 510(k) number is K211206.

When did FreedomEdge(R) Syringe Infusion System receive FDA 510(k) clearance?

FreedomEdge(R) Syringe Infusion System received FDA 510(k) clearance on 2021-11-09, under 510(k) number K211206.

Who is the listed applicant for FreedomEdge(R) Syringe Infusion System?

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

What is the FDA product code for FreedomEdge(R) Syringe Infusion System?

The FDA product code for FreedomEdge(R) Syringe Infusion System is FRN.

其他以 Repro-Medical System, Inc., Dba Koru Medical Systems 為申請人之記錄

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K214045FreedomEdge 靜脈注射系統

相關器械（代碼：FRN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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