FDA 510(k)

KLOCKNER外科箱

K 號：K173642 · 2018-10-02

決定日期2018-10-02

產品代碼KCT

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

KLOCKNER SURGICAL BOX is the device name listed in this FDA 510(k) record. The listed applicant is SOADCO, S.L.. It received FDA 510(k) clearance on 2018-10-02 under 510(k) number K173642. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KLOCKNER SURGICAL BOX?

KLOCKNER SURGICAL BOX is a medical device that received FDA 510(k) clearance on 2018-10-02. The listed applicant is SOADCO, S.L.. The 510(k) number is K173642.

When did KLOCKNER SURGICAL BOX receive FDA 510(k) clearance?

KLOCKNER SURGICAL BOX received FDA 510(k) clearance on 2018-10-02, under 510(k) number K173642.

Who is the listed applicant for KLOCKNER SURGICAL BOX?

The FDA 510(k) record lists SOADCO, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KLOCKNER SURGICAL BOX?

The FDA product code for KLOCKNER SURGICAL BOX is KCT.

其他以 SOADCO, S.L. 為申請人之記錄

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相關器械（代碼：KCT）

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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