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    K Number
    K081951
    Device Name
    ANEROID SPHYGMOMANOMETER, MODEL KT-A01
    Manufacturer
    WENZHOU KINDCARE IMPORT & EXPORT CO., LTD
    Date Cleared
    2008-08-15

    (37 days)

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

    **WENZHOU KINDCARE IMPORT **& EXPORT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Aneroid Sphygmomanometer Model KT-A01 with Stethoscope is a non-automated, mechanical 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 hospitals or at home to monitor both systolic and diastolic pressure. This device is sold with an adult D size cuff and suitable for use on adults.
    Device Description
    The Aneroid Sphygmomanomefer Model KT-A01 with Stethoscope 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.
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