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510(k) Data Aggregation

    K Number
    K990638
    Device Name
    ANEROID SPHYGMOMANOMETER
    Manufacturer
    GENMED, INC.
    Date Cleared
    1999-10-07

    (223 days)

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

    GENMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Knorokoff sounds. This device is indicated for use by medical personnel or for home use.
    Device Description
    Genmed Aneroid Sphygmomanometer
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