視界DR+無線
K 號：K160810 · 2016-05-20
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器材摘要
ViZion DR + Wireless is the device name listed in this FDA 510(k) record. The listed applicant is Viztek, LLC. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K160810. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ViZion DR + Wireless?
ViZion DR + Wireless is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Viztek, LLC. The 510(k) number is K160810.
When did ViZion DR + Wireless receive FDA 510(k) clearance?
ViZion DR + Wireless received FDA 510(k) clearance on 2016-05-20, under 510(k) number K160810.
Who is the listed applicant for ViZion DR + Wireless?
The FDA 510(k) record lists Viztek, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ViZion DR + Wireless?
The FDA product code for ViZion DR + Wireless is MQB.
相關臨床試驗
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相關器械（代碼：MQB）
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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