FDA 510(k)

整合追趕自由針筒輸液系統

K 號：K162613 · 2017-08-31

申請人Repro-Med Systems, Inc. Dba Rms Medical Products

決定日期2017-08-31

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

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.

常見問題

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.

其他以 Repro-Med Systems, Inc. Dba Rms Medical Products 為申請人之記錄

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