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510(k) Data Aggregation

    K Number
    K122259
    Device Name
    BLOOD PRESSURE MONITOR WITH STETHOSCOPE
    Date Cleared
    2012-09-24

    (59 days)

    Product Code
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANGZHOU RELI-ON CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Blood pressure monitor with stethoscope, Model HBPK-A is a non-automated, aneroid blood pressure monitor that is used for the indirect measurement (noninvasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospital or at home to monitor both systolic and diastolic pressure. This device is sold with an adult D-ring cuff and suitable for use on adult.
    Device Description
    Blood pressure monitor with stethoscope, Model HBPK-A is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff, an aneroid manometer to measure pressure, and a stethoscope for detecting Korotkoff sounds. The Aneroid Sphygmomanometer with Stethoscope contains: - 1. Adjustable D-ring Cuff (Adult Size) - 2. Stethoscope (Attaches to the cuff) - 3. Non-stop rotary pin. 300 mmHq gauge - 4. Instruction booklet and record - 4. Carrying case -The Blood pressure monitor with stethoscope enables the user to monitor the pressure of flowing blood that is exerted against the arteries at highest (systolic or contraction) and lowest (diastolic or relaxation) pressure. To operate, the user places the attached stethoscope on the inner arm above the bend in the elbow, to detect the pulse of the brachial artery. After inflation of the cuff, the user does auditory monitoring with the stethoscope to evaluate systolic and diastolic pressure. The two values are usually recorded as a ratio of the two measurements: systolic over diastolic.
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