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510(k) Data Aggregation

    K Number
    K191209
    Device Name
    Aneroid Type Blood Pressure Kit
    Date Cleared
    2019-06-18

    (43 days)

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

    Dongguan Mars Medical Products Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to be used by medical professionals or in the measurement of systolic and diastolic pressure. The models MS-200, MS-200M are intended to be manually attached to a patient and manually inflated along with a manual method.
    Device Description
    Aneroid Type Blood Pressure Kit, models MS-200D and MS-200M are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. The proposed device has three models, MS-200/MS-200D/MS-200M. The three models have same intended use, same design and measuring principle, same measuring range and same main components. The only differences among the three models are assembly accessories for fixation and installation of the aneroid sphygmomanometer.
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