藥劑適配器
K 號：K232055 · 2023-10-06
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決定日期2023-10-06
產品代碼LHI
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
Vial Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Lingfu Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K232055. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Vial Adapter?
Vial Adapter is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Shanghai Lingfu Technology Co., Ltd.. The 510(k) number is K232055.
When did Vial Adapter receive FDA 510(k) clearance?
Vial Adapter received FDA 510(k) clearance on 2023-10-06, under 510(k) number K232055.
Who is the listed applicant for Vial Adapter?
The FDA 510(k) record lists Shanghai Lingfu Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Vial Adapter?
The FDA product code for Vial Adapter is LHI.
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。
相關器械（代碼：LHI）
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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