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510(k) Data Aggregation

    K Number
    K040410
    Device Name
    GREENLIGHT 300
    Date Cleared
    2004-05-05

    (77 days)

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

    **A C COSSOR **& SON (SURGICAL) LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to be used by medical professionals only for the measurement of systolic and diastolic blood pressure values. The device is intended to be used with blood pressure cuffs supplied for use with the device which are manually attached to a patient and manually inflated, with a manual method for detecting Korotkoff sounds. The device cuffs are available in a range of adult, pediatric and neonate sizes for use in exactly the same way and substantially equivalent to the Accoson greenlight 300 sphygmomanometer under 510(k) number K970111 for adult, pediatric and neonate patient groups.
    Device Description
    Accoson Greenlight 300 Sphygmomanometer
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