Astell UMB 220, UMB 230, UMB 240 蒸汽滅菌器/消毒器
K 號：K170304 · 2018-03-02
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決定日期2018-03-02
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
Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers is the device name listed in this FDA 510(k) record. The listed applicant is Astell Scientific Limited. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K170304. 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 Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers?
Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Astell Scientific Limited. The 510(k) number is K170304.
When did Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers receive FDA 510(k) clearance?
Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers received FDA 510(k) clearance on 2018-03-02, under 510(k) number K170304.
Who is the listed applicant for Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers?
The FDA 510(k) record lists Astell Scientific Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers?
The FDA product code for Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers is FLE.
相關臨床試驗
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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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