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510(k) Data Aggregation

    K Number
    K043444
    Device Name
    MULTIPLE, MODEL KTJ-50
    Manufacturer
    GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD.
    Date Cleared
    2005-02-22

    (70 days)

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

    GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multiple Brand, with model number KTJ-50, aneroid sphygmomanometer is an instrument intended to be used for the indirect (noninvasive) measurement of human's Systolic, Diastolic blood pressure using the auscultatory method by detecting Korotkoff Sound. This device is to be used by trained medical and health care personnel or trained general users.
    Device Description
    The aneroid sphygmomanometer with stethoscope is a non-invasive blood pressure measurement system for monitoring blood pressure levels which can be performed by trained individuals. The sphygmomanometer Model KTJ-50 consists of 5 parts. They are aneroid manometer, latex bulb, cuff, valve and stethoscope set. The aneroid sphygmomanometer with stethoscope enables the user places the attached stethoscope on the inner arm above the bend in the elbow, to detect the Korotkoff sound. After inflation of the user does auditory monitor with the stethoscope to evaluate systolic and diastolic pressure. The two values are recorded as: systolic over diastolic.
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    K Number
    K010686
    Device Name
    KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C
    Manufacturer
    GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD.
    Date Cleared
    2001-03-21

    (13 days)

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

    GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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