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

    Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683

    K Number: K222926 · Decision May 5, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    3
    Review Days
    221

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    Basic Information

    Device Name
    Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683
    K Number
    K222926
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Yuezhongxing Technology Co., Ltd.
    Date Received
    September 26, 2022
    Decision Date
    May 5, 2023
    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 Yuezhongxing Technology Co., Ltd.

    K Number Device Name
    K233799 Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R)
    K211041 Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681