EUROPA™導航儀器
K 號：K230369 · 2023-06-23
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器材摘要
EUROPA™ Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K230369. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the EUROPA™ Navigated Instruments?
EUROPA™ Navigated Instruments is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is MiRus, LLC. The 510(k) number is K230369.
When did EUROPA™ Navigated Instruments receive FDA 510(k) clearance?
EUROPA™ Navigated Instruments received FDA 510(k) clearance on 2023-06-23, under 510(k) number K230369.
Who is the listed applicant for EUROPA™ Navigated Instruments?
The FDA 510(k) record lists MiRus, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EUROPA™ Navigated Instruments?
The FDA product code for EUROPA™ Navigated Instruments is OLO.
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。
其他以 MiRus, 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：OLO）
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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