FDA 510(k)

系統1內鏡液體化學消毒處理系統，型號P6900

K 號：K230582 · 2023-03-28

決定日期2023-03-28

產品代碼MED

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

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2023-03-28 under 510(k) number K230582. The device is classified under product code MED. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900?

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is a medical device that received FDA 510(k) clearance on 2023-03-28. The listed applicant is STERIS Corporation. The 510(k) number is K230582.

When did SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 receive FDA 510(k) clearance?

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 received FDA 510(k) clearance on 2023-03-28, under 510(k) number K230582.

Who is the listed applicant for SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900?

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

What is the FDA product code for SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900?

The FDA product code for SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is MED.

其他以 STERIS Corporation 為申請人之記錄

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相關器械（代碼：MED）

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。

官方來源

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