FDA 510(k)

Midmark Smart M9® 過濾器，Midmark Smart M11® 過濾器

K 號：K233026 · 2024-04-04

決定日期2024-04-04

產品代碼FLE

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

Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Midmark Corporation. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K233026. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer?

Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Midmark Corporation. The 510(k) number is K233026.

When did Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer receive FDA 510(k) clearance?

Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer received FDA 510(k) clearance on 2024-04-04, under 510(k) number K233026.

Who is the listed applicant for Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer?

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

What is the FDA product code for Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer?

The FDA product code for Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer is FLE.

其他以 Midmark Corporation 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：FLE）

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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