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

    Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)

    K Number: K241634 · Decision Feb 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    2
    Review Days
    250

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    Basic Information

    Device Name
    Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
    K Number
    K241634
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangdong Xinyu Electronic and Technology Co., Ltd.
    Date Received
    June 6, 2024
    Decision Date
    February 11, 2025
    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 Guangdong Xinyu Electronic and Technology Co., Ltd.

    K Number Device Name
    K241590 Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)