FDA 510(k)U80系列上臂電子血壓監測器
K 號：K160019 · 2016-04-22
決定日期2016-04-22
產品代碼DXN
諮詢委員會履歷
決定相當於
器材摘要
U80 Series Upper Arm Electronic Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Urion Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-04-22 under 510(k) number K160019. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the U80 Series Upper Arm Electronic Blood Pressure Monitor?
U80 Series Upper Arm Electronic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is Shenzhen Urion Technology Co., Ltd.. The 510(k) number is K160019.
When did U80 Series Upper Arm Electronic Blood Pressure Monitor receive FDA 510(k) clearance?
U80 Series Upper Arm Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2016-04-22, under 510(k) number K160019.
Who is the listed applicant for U80 Series Upper Arm Electronic Blood Pressure Monitor?
The FDA 510(k) record lists Shenzhen Urion Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for U80 Series Upper Arm Electronic Blood Pressure Monitor?
The FDA product code for U80 Series Upper Arm Electronic Blood Pressure Monitor is DXN.
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其他以 Shenzhen Urion Technology Co., Ltd. 為申請人之記錄
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相關器械（代碼：DXN）
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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