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510(k) Data Aggregation

    K Number
    K012444
    Device Name
    ABN ANEROID SPHYGMOMANOMETER
    Manufacturer
    PT. SUGIH INSTRUMENDO ABADI
    Date Cleared
    2001-08-16

    (15 days)

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

    PT. SUGIH INSTRUMENDO ABADI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure blood pressure by means of a manually inflatable cuff and a manometer analog gauge. These devices will be used by physicians, nurses, paramedics and retail consumers.
    Device Description
    An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure blood pressure by means of a manually inflatable cuff and a manometer analog gauge.
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