通氣瓶蓋針20mm
K 號：K213513 · 2022-08-31
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決定日期2022-08-31
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
Vented Vial Adapter 20mm is the device name listed in this FDA 510(k) record. The listed applicant is West Pharma. Services IL, Ltd.. It received FDA 510(k) clearance on 2022-08-31 under 510(k) number K213513. 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 Vented Vial Adapter 20mm?
Vented Vial Adapter 20mm is a medical device that received FDA 510(k) clearance on 2022-08-31. The listed applicant is West Pharma. Services IL, Ltd.. The 510(k) number is K213513.
When did Vented Vial Adapter 20mm receive FDA 510(k) clearance?
Vented Vial Adapter 20mm received FDA 510(k) clearance on 2022-08-31, under 510(k) number K213513.
Who is the listed applicant for Vented Vial Adapter 20mm?
The FDA 510(k) record lists West Pharma. Services IL, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Vented Vial Adapter 20mm?
The FDA product code for Vented Vial Adapter 20mm 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。
其他以 West Pharma. Services IL, Ltd. 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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