黑钻導航儀器
K 號：K192495 · 2020-01-17
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器材摘要
Black Diamond Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Osseus Fusion Systems. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K192495. 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 Black Diamond Navigation Instruments?
Black Diamond Navigation Instruments is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Osseus Fusion Systems. The 510(k) number is K192495.
When did Black Diamond Navigation Instruments receive FDA 510(k) clearance?
Black Diamond Navigation Instruments received FDA 510(k) clearance on 2020-01-17, under 510(k) number K192495.
Who is the listed applicant for Black Diamond Navigation Instruments?
The FDA 510(k) record lists Osseus Fusion Systems as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Black Diamond Navigation Instruments?
The FDA product code for Black Diamond Navigation Instruments is OLO.
相關臨床試驗
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其他以 Osseus Fusion Systems 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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