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510(k) Data Aggregation

    K Number
    K220886
    Device Name
    Upper Arm Type Blood Pressure Monitor
    Date Cleared
    2022-07-27

    (121 days)

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

    Shenzhen Jamr Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Upper Arm Type Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult by using the arm cuff (22-42cm), it can be used in medical facilities or at home. It is supplied for OTC use.
    Device Description
    The proposed device, Upper Arm Type Blood Pressure Monitor, is a battery or AC adaptor driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at wrist within its claimed range and accuracy via the oscillometric technique. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2. The proposed device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use. The proposed blood pressure monitor includes 2 models, which are F1701T, F1701TA. All models follow the same software, measurement principle and NIBP algorithm. The main difference is the deflation valve.
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