Cordiana Dx16
K 號：K201060 · 2020-11-16
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器材摘要
Cordiana Dx16 is the device name listed in this FDA 510(k) record. The listed applicant is Cordiana Medical Informatics AG. It received FDA 510(k) clearance on 2020-11-16 under 510(k) number K201060. 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 Cordiana Dx16?
Cordiana Dx16 is a medical device that received FDA 510(k) clearance on 2020-11-16. The listed applicant is Cordiana Medical Informatics AG. The 510(k) number is K201060.
When did Cordiana Dx16 receive FDA 510(k) clearance?
Cordiana Dx16 received FDA 510(k) clearance on 2020-11-16, under 510(k) number K201060.
Who is the listed applicant for Cordiana Dx16?
The FDA 510(k) record lists Cordiana Medical Informatics AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cordiana Dx16?
The FDA product code for Cordiana Dx16 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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