迷你CAT 2D
K 號：K201825 · 2020-11-20
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器材摘要
MiniCAT 2D is the device name listed in this FDA 510(k) record. The listed applicant is Xoran Technologies, LLC. It received FDA 510(k) clearance on 2020-11-20 under 510(k) number K201825. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MiniCAT 2D?
MiniCAT 2D is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Xoran Technologies, LLC. The 510(k) number is K201825.
When did MiniCAT 2D receive FDA 510(k) clearance?
MiniCAT 2D received FDA 510(k) clearance on 2020-11-20, under 510(k) number K201825.
Who is the listed applicant for MiniCAT 2D?
The FDA 510(k) record lists Xoran Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MiniCAT 2D?
The FDA product code for MiniCAT 2D is KPR.
相關臨床試驗
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其他以 Xoran Technologies, LLC 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：KPR）
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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