K243115

Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))

510(k) 号: K243115
器械名称: Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))
申请人: Shenzhen Urion Technology Co., Ltd. CN
产品代码: DXN — System, Measurement, Blood-Pressure, Non-Invasive
批准日期: 2025-02-21
受理日期: 2024-09-30
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Cardiovascular

PDF下载 510(k) Summary本站存档 · 1.0 MB · FDA 公有领域文件

也可从 FDA 官方下载： K243115.pdf

FDA 官方记录： K243115

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。