蒸汽滅菌器系列 B17 B22 家族
K 號：K161848 · 2017-02-23
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申請人Cefla S.C.
決定日期2017-02-23
產品代碼FLE
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
Family of Steam sterilizers B17 B22 Series is the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K161848. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Family of Steam sterilizers B17 B22 Series?
Family of Steam sterilizers B17 B22 Series is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Cefla S.C.. The 510(k) number is K161848.
When did Family of Steam sterilizers B17 B22 Series receive FDA 510(k) clearance?
Family of Steam sterilizers B17 B22 Series received FDA 510(k) clearance on 2017-02-23, under 510(k) number K161848.
Who is the listed applicant for Family of Steam sterilizers B17 B22 Series?
The FDA 510(k) record lists Cefla S.C. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Family of Steam sterilizers B17 B22 Series?
The FDA product code for Family of Steam sterilizers B17 B22 Series is FLE.
相關臨床試驗
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其他以 Cefla S.C. 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：FLE）
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。
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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