FDA 510(k)

Aesculap® 無菌容器 (TM) S2 系統

K 號：K182414 · 2019-07-05

決定日期2019-07-05

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

Aesculap® SterilContainer(TM) S2 System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2019-07-05 under 510(k) number K182414. 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 Aesculap® SterilContainer(TM) S2 System?

Aesculap® SterilContainer(TM) S2 System is a medical device that received FDA 510(k) clearance on 2019-07-05. The listed applicant is Aesculap, Inc.. The 510(k) number is K182414.

When did Aesculap® SterilContainer(TM) S2 System receive FDA 510(k) clearance?

Aesculap® SterilContainer(TM) S2 System received FDA 510(k) clearance on 2019-07-05, under 510(k) number K182414.

Who is the listed applicant for Aesculap® SterilContainer(TM) S2 System?

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

What is the FDA product code for Aesculap® SterilContainer(TM) S2 System?

The FDA product code for Aesculap® SterilContainer(TM) S2 System is KCT.

其他以 Aesculap, Inc. 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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