Navik 3D
K 號：K152160 · 2016-02-23
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器材摘要
Navik 3D is the device name listed in this FDA 510(k) record. The listed applicant is Apn Health, LLC. It received FDA 510(k) clearance on 2016-02-23 under 510(k) number K152160. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Navik 3D?
Navik 3D is a medical device that received FDA 510(k) clearance on 2016-02-23. The listed applicant is Apn Health, LLC. The 510(k) number is K152160.
When did Navik 3D receive FDA 510(k) clearance?
Navik 3D received FDA 510(k) clearance on 2016-02-23, under 510(k) number K152160.
Who is the listed applicant for Navik 3D?
The FDA 510(k) record lists Apn Health, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Navik 3D?
The FDA product code for Navik 3D is DQK.
相關臨床試驗
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相關器械（代碼：DQK）
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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