Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250091
    Device Name
    KOROT Blood Pressure Monitor (KOROT P3 Accurate)
    Manufacturer
    Korot Co. Ltd.
    Date Cleared
    2025-03-14

    (59 days)

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

    Korot Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This blood pressure monitor is designed to measure blood pressure (diastolic and pulse rate in adult patients with arm circumference range between 22 cm - 52 cm.
    Device Description
    The KOROT P3 Accurate is a digital monitor intended for use in measuring blood pressure and pulse rate in adults with upper arm circumference ranging from 22cm (9-inch to 20-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method and also by utilizing the Auto auscultation method and Oscillometric method. The KOROT P3 Accurate may provide useful clinical information about the current health status of not only the users who are diagnosed with hypertension but also those who are not diagnosed with hypertension. Blood pressure is the measurement of pressure of blood vessels. Blood vessels. Blood pressure can be measured by direct or indirect measurement supports indirect measurement using cuff. This equipment tracks and analyzes the blood flow oscillations under the pressure using the highest to the lowest pressure as shown by the figure below when the minute pressure speed is determined by the heartbeat. This equipment adopts Oscillometric method and automated auscultation method using a cuff for blood pressure measurement. In case of Oscilometric method, the device determines the systolic, diastolic and pulse rate on the blood flow oscillations measured through the cuff. On the other hands, in case of Auto auscultation method that combines the accuracy of auscultation, which is regarded as the gold standard for blood pressure measurement. To measure the blood pressure, wap the upper arm and inflate it to a pressure above the systolic pressure. Then slowly release the Korotkoff sound signal and the pressure sensor signal, which you can catch with the sensor attached to the cuff, to measure the systolic blood pressure. The Automated Auscultation applied to KOROT P3 Accurate combines the accuracy of the auscultation method staffs hear directly with the convenience of easy measurement. The signals are electronically processed to compensate for the possible errors in the auscultation method caused by movement, external noise, etc., enabling a more accurate blood pressure measurement.
    Ask a Question

    Page 1 of 1