FDA 510(k)

異種移植遞送設備（OFAC-C）

K 號：K201338 · 2020-07-13

決定日期2020-07-13

產品代碼FMF

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

Allograft MIS Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Lifenet Health. It received FDA 510(k) clearance on 2020-07-13 under 510(k) number K201338. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Allograft MIS Delivery System?

Allograft MIS Delivery System is a medical device that received FDA 510(k) clearance on 2020-07-13. The listed applicant is Lifenet Health. The 510(k) number is K201338.

When did Allograft MIS Delivery System receive FDA 510(k) clearance?

Allograft MIS Delivery System received FDA 510(k) clearance on 2020-07-13, under 510(k) number K201338.

Who is the listed applicant for Allograft MIS Delivery System?

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

What is the FDA product code for Allograft MIS Delivery System?

The FDA product code for Allograft MIS Delivery System is FMF.

其他以 Lifenet Health 為申請人之記錄

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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相關器械（代碼：FMF）

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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