TRINITY
K 號：K160357 · 2016-05-02
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器材摘要
TRINITY is the device name listed in this FDA 510(k) record. The listed applicant is Koelis. It received FDA 510(k) clearance on 2016-05-02 under 510(k) number K160357. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TRINITY?
TRINITY is a medical device that received FDA 510(k) clearance on 2016-05-02. The listed applicant is Koelis. The 510(k) number is K160357.
When did TRINITY receive FDA 510(k) clearance?
TRINITY received FDA 510(k) clearance on 2016-05-02, under 510(k) number K160357.
Who is the listed applicant for TRINITY?
The FDA 510(k) record lists Koelis as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TRINITY?
The FDA product code for TRINITY is IYN.
相關臨床試驗
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其他以 Koelis 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：IYN）
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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