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510(k) Data Aggregation

    K Number
    K153033
    Device Name
    Digital Blood Pressure Monitor
    Date Cleared
    2016-06-24

    (249 days)

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

    SUZHOU SUNSPIRI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended to measure the blood pressure and pulse rate on upper arms of adults.
    Device Description
    The Digital Blood Pressure Monitor is Arm-type fully automatic Digital Blood Pressure Monitor and used the oscillometric method for non-invasive measurement of blood-pressure at home. The equipment is non-transit-operable, portable equipment, not used at the conditions of patient movement in normal use. The unit is powered by internal dry battery. Digital Blood Pressure Monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate. Digital Blood Pressure Monitor, JDS-189, JDS-500A, JDS-500E, JDS-600, JDS-700, JDS-703, JDS-704, JDS-800, BM 20 in term of intended use measurement method, structure, and specifications are totally same, only the appearance, memory space has difference.
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