ONE TRAY® 密封消毒容器系統
K 號：K250029 · 2025-05-01
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決定日期2025-05-01
產品代碼KCT
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
ONE TRAY® Sealed Sterilization Container System is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Sterilization Technologies. It received FDA 510(k) clearance on 2025-05-01 under 510(k) number K250029. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ONE TRAY® Sealed Sterilization Container System?
ONE TRAY® Sealed Sterilization Container System is a medical device that received FDA 510(k) clearance on 2025-05-01. The listed applicant is Innovative Sterilization Technologies. The 510(k) number is K250029.
When did ONE TRAY® Sealed Sterilization Container System receive FDA 510(k) clearance?
ONE TRAY® Sealed Sterilization Container System received FDA 510(k) clearance on 2025-05-01, under 510(k) number K250029.
Who is the listed applicant for ONE TRAY® Sealed Sterilization Container System?
The FDA 510(k) record lists Innovative Sterilization Technologies as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ONE TRAY® Sealed Sterilization Container System?
The FDA product code for ONE TRAY® Sealed Sterilization Container System is KCT.
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。
相關器械（代碼：KCT）
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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