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510(k) Data Aggregation

    K Number
    K172894
    Device Name
    Infrared Thermometer
    Date Cleared
    2018-05-17

    (237 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Jiacom Technology Co ., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Infrared Thermometer is intended to detect body temperature from the forehead or auditory canal in the population including infant (above 6 months), child, adolescent, and adult
    Device Description
    The proposed device, Infrared Thermometers IFR 600 is hand-held, reusable, battery powered device, which is intended to detect body temperature from forehead or auditory canal in the pediatric and adult population. IFR 600 infrared thermometer can measure human body temperature by both ear and forehead measurement.
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    K Number
    K172896
    Device Name
    Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312
    Date Cleared
    2018-01-26

    (126 days)

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

    Shenzhen Jiacom Technology Co ., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Arm Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm. It can be used at medical facilities or at home. The intended arm circumference is 22-32 cm.
    Device Description
    The proposed device, Arm Type Automatic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa. 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 9 models, which are BP310A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, and BP-JC312. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.
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