FDA 510(k)

EOGas 4 結腸-菌種測試

K 號：K192980 · 2020-11-12

決定日期2020-11-12

產品代碼FRC

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

EOGas 4 Endo-SteriTest is the device name listed in this FDA 510(k) record. The listed applicant is Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2020-11-12 under 510(k) number K192980. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EOGas 4 Endo-SteriTest?

EOGas 4 Endo-SteriTest is a medical device that received FDA 510(k) clearance on 2020-11-12. The listed applicant is Andersen Sterilizers, Inc.. The 510(k) number is K192980.

When did EOGas 4 Endo-SteriTest receive FDA 510(k) clearance?

EOGas 4 Endo-SteriTest received FDA 510(k) clearance on 2020-11-12, under 510(k) number K192980.

Who is the listed applicant for EOGas 4 Endo-SteriTest?

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

What is the FDA product code for EOGas 4 Endo-SteriTest?

The FDA product code for EOGas 4 Endo-SteriTest is FRC.

其他以 Andersen Sterilizers, Inc. 為申請人之記錄

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相關器械（代碼：FRC）

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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