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510(k) Data Aggregation

    K Number
    K251307

    Validate with FDA (Live)

    Device Name
    Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)
    Manufacturer
    Shenzhen Hingmed Medical Instrument Co., Ltd.
    Date Cleared
    2026-01-12

    (259 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    18 - 64
    Reference & Predicate Devices
    K231984
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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(contraindicate the home as an environment of use).

    Patient population: Adult (exclude pregnant women ).

    Device Description

    Clinical Automatic blood pressure monitor have two type that is DBP-20 and DBP-20i,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 adapter.The device can show the time and measure result .There is a difference DBP-20 and DBP -20i. The difference is the function with voice broadcast . DBP-20i have the function which broadcast the measure result.and DBP-20 have not the broadcasting function.

    Clinical Automatic Blood Pressure Monitor is intended to be used for arms range from 17 to 42cm in circumference. The cuff cover can be replace easily. The device intended use at medical center .

    AI/ML Overview

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