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510(k) Data Aggregation

    K Number
    K181154
    Device Name
    Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor
    Manufacturer
    Shenzhen Med-link Electronics Tech Co, Ltd.
    Date Cleared
    2019-08-02

    (458 days)

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

    Shenzhen Med-link Electronics Tech Co, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Med-link Wrist Digital Blood Pressure Monitor is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm. Med-link Upper Arm Digital Blood Pressure Monitor is non-invasive measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the upper arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-32cm.
    Device Description
    The proposed devices are battery driven automatic non-invasive blood pressure Monitor. It is used for automatically conduct the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist or upper arm within its claimed range and accuracy by oscillometry technique. Devices are consisted of three main parts: external hardwares (such as cuff), analog circuit, and MCU. The devices have the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The proposed devices are intended to be used in medical facilities or at home and provided non-sterile. The proposed devices have 2 models: Med-link Wrist Digital Blood Pressure Monitor Model:ESM101 Med-link Upper Arm Digital Blood Pressure Monitor Model:ESM201
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