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K 號：K163149 · 2017-04-26
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器材摘要
VisualEyes is the device name listed in this FDA 510(k) record. The listed applicant is Interacoustics A/S. It received FDA 510(k) clearance on 2017-04-26 under 510(k) number K163149. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the VisualEyes?
VisualEyes is a medical device that received FDA 510(k) clearance on 2017-04-26. The listed applicant is Interacoustics A/S. The 510(k) number is K163149.
When did VisualEyes receive FDA 510(k) clearance?
VisualEyes received FDA 510(k) clearance on 2017-04-26, under 510(k) number K163149.
Who is the listed applicant for VisualEyes?
The FDA 510(k) record lists Interacoustics A/S as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VisualEyes?
The FDA product code for VisualEyes is GWN.
相關臨床試驗
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其他以 Interacoustics A/S 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：GWN）
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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