FDA 510(k)

閉合男性路爾插頭

K 號：K171101 · 2017-06-02

決定日期2017-06-02

產品代碼FPA

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

Closed Male Luer is the device name listed in this FDA 510(k) record. The listed applicant is Yukon Medical. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K171101. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Closed Male Luer?

Closed Male Luer is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Yukon Medical. The 510(k) number is K171101.

When did Closed Male Luer receive FDA 510(k) clearance?

Closed Male Luer received FDA 510(k) clearance on 2017-06-02, under 510(k) number K171101.

Who is the listed applicant for Closed Male Luer?

The FDA 510(k) record lists Yukon Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Closed Male Luer?

The FDA product code for Closed Male Luer is FPA.

其他以 Yukon Medical 為申請人之記錄

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官方來源

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