Scopis雙模態導航系統 EM
K 號：K161491 · 2017-02-09
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器材摘要
Scopis Hybrid Navigation System EM is the device name listed in this FDA 510(k) record. The listed applicant is Scopis GmbH. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K161491. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Scopis Hybrid Navigation System EM?
Scopis Hybrid Navigation System EM is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Scopis GmbH. The 510(k) number is K161491.
When did Scopis Hybrid Navigation System EM receive FDA 510(k) clearance?
Scopis Hybrid Navigation System EM received FDA 510(k) clearance on 2017-02-09, under 510(k) number K161491.
Who is the listed applicant for Scopis Hybrid Navigation System EM?
The FDA 510(k) record lists Scopis GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Scopis Hybrid Navigation System EM?
The FDA product code for Scopis Hybrid Navigation System EM is PGW.
相關臨床試驗
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其他以 Scopis GmbH 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：PGW）
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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