BD Texium™ 關閉男性 Luer
K 號：K223076 · 2023-03-24
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申請人Care Fusion
決定日期2023-03-24
產品代碼ONB
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
BD Texium™ Closed Male Luer is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2023-03-24 under 510(k) number K223076. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BD Texium™ Closed Male Luer?
BD Texium™ Closed Male Luer is a medical device that received FDA 510(k) clearance on 2023-03-24. The listed applicant is Care Fusion. The 510(k) number is K223076.
When did BD Texium™ Closed Male Luer receive FDA 510(k) clearance?
BD Texium™ Closed Male Luer received FDA 510(k) clearance on 2023-03-24, under 510(k) number K223076.
Who is the listed applicant for BD Texium™ Closed Male Luer?
The FDA 510(k) record lists Care Fusion as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BD Texium™ Closed Male Luer?
The FDA product code for BD Texium™ Closed Male Luer is ONB.
相關臨床試驗
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。
其他以 Care Fusion 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。
相關器械（代碼：ONB）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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