蒸汽滅菌器系列 B 28
K 號：K151597 · 2016-03-04
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申請人Cefla S.C.
決定日期2016-03-04
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 B 28 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 2016-03-04 under 510(k) number K151597. 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 B 28 series?
Family of Steam Sterilizers B 28 series is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Cefla S.C.. The 510(k) number is K151597.
When did Family of Steam Sterilizers B 28 series receive FDA 510(k) clearance?
Family of Steam Sterilizers B 28 series received FDA 510(k) clearance on 2016-03-04, under 510(k) number K151597.
Who is the listed applicant for Family of Steam Sterilizers B 28 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 B 28 series?
The FDA product code for Family of Steam Sterilizers B 28 series is FLE.
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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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