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510(k) Data Aggregation

    K Number
    K103046
    Device Name
    HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE
    Date Cleared
    2011-01-10

    (88 days)

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

    HOSMAN INTERNATIONAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HOSMAN USB Blood Pressure Monitor, Upper Arm Type: HM-500 and Wrist Type: HM-100, are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist or upper arm. The cuff circumference is limited to be 5.3'~7.7' (13.5 cm~19.5 cm) for wrist type; and 8.7'~14.6' (22 cm~37 cm) for Upper Arm type.
    Device Description
    HOSMAN USB Blood Pressure Monitor Upper Arm Type: HM-500 and Wrist Type: HM-100 use the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
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