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510(k) Data Aggregation

    K Number
    K230176
    Device Name
    Upper Arm Blood Pressure Monitor
    Manufacturer
    Shenzhen Yolanda Technology Co., Ltd.
    Date Cleared
    2023-06-29

    (157 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Yolanda Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Upper Arm Blood pressure Monitor a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm of which the circumference includes 22 cm~42 cm or 22cm~48cm. It is intended to be used in hospital environment or at home.
    Device Description
    Upper Arm Blood pressure Monitor (Model:SP10A).
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