BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)

    K Number: K241007 · Decision Oct 24, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    8
    Review Days
    195

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    Basic Information

    Device Name
    Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
    K Number
    K241007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Urion Technology Co., Ltd.
    Date Received
    April 12, 2024
    Decision Date
    October 24, 2024
    Product Code
    DXN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    Other Clearances by Shenzhen Urion Technology Co., Ltd.

    K Number Device Name
    K254048 Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
    K260273 Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
    K250046 Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)
    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))
    K200802 Infrared Thermometer
    K160019 U80 Series Upper Arm Electronic Blood Pressure Monitor
    K141683 ELECTRONIC BLOOD PRESSURE MONITOR