SmartSite™ 通氣安瓿瓶進入設備
K 號：K243486 · 2024-12-06
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決定日期2024-12-06
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
SmartSiteTM Vented Vial Access Device is the device name listed in this FDA 510(k) record. The listed applicant is Yukon Medical, LLC. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K243486. 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 SmartSiteTM Vented Vial Access Device?
SmartSiteTM Vented Vial Access Device is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Yukon Medical, LLC. The 510(k) number is K243486.
When did SmartSiteTM Vented Vial Access Device receive FDA 510(k) clearance?
SmartSiteTM Vented Vial Access Device received FDA 510(k) clearance on 2024-12-06, under 510(k) number K243486.
Who is the listed applicant for SmartSiteTM Vented Vial Access Device?
The FDA 510(k) record lists Yukon Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmartSiteTM Vented Vial Access Device?
The FDA product code for SmartSiteTM Vented Vial Access Device is LHI.
相關臨床試驗
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其他以 Yukon Medical, LLC 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：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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