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510(k) Data Aggregation

    K Number
    K231984
    Device Name
    Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)
    Date Cleared
    2024-03-26

    (265 days)

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

    Shenzhen Hingmed Medical Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is a digital monitor intended for use in measuring blood pressure(SYS and DIA) and pulse rate ,and the physician reference the result to diagnose. Environments of use: Hospital and other medical establishment. Patient population: Adult (exclude pregnant women ).
    Device Description
    Clinical Automatic blood pressure monitor have two models that are DBP-01HP and DBP-01P,The Clinical Automatic blood pressure monitor is used to measure the blood pressure of adult in hospital or other medical establishment. It's contain of main body , power wire.it can show the time and measure result, print the measure result .There is a difference between DBP-01HP with DBP -01P. DBP-01HP show the measure result and time by the LCD screen,DBP-01P show the measure result and time by the LED screen.
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