FDA 510(k)

Qitexio® 4向止回閥 (QIT014)

K 號：K242255 · 2025-04-29

申請人Medex

決定日期2025-04-29

產品代碼FMG

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

Qitexio® 4-Way Stopcock (QIT014) is the device name listed in this FDA 510(k) record. The listed applicant is Medex. It received FDA 510(k) clearance on 2025-04-29 under 510(k) number K242255. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Qitexio® 4-Way Stopcock (QIT014)?

Qitexio® 4-Way Stopcock (QIT014) is a medical device that received FDA 510(k) clearance on 2025-04-29. The listed applicant is Medex. The 510(k) number is K242255.

When did Qitexio® 4-Way Stopcock (QIT014) receive FDA 510(k) clearance?

Qitexio® 4-Way Stopcock (QIT014) received FDA 510(k) clearance on 2025-04-29, under 510(k) number K242255.

Who is the listed applicant for Qitexio® 4-Way Stopcock (QIT014)?

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

What is the FDA product code for Qitexio® 4-Way Stopcock (QIT014)?

The FDA product code for Qitexio® 4-Way Stopcock (QIT014) is FMG.

其他以 Medex 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。

K203738Qitexio

相關器械（代碼：FMG）

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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