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    K Number
    K022304
    Device Name
    ACCUMAP AUTOMATIC PERIMETER
    Manufacturer
    OBJECTIVISION PTY LTD.
    Date Cleared
    2003-11-14

    (486 days)

    Product Code
    GWE
    Regulation Number
    882.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    OBJECTIVISION PTY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AccuMap® perimetry system uses multifocal recordings of visual evoked potentials as a diagnostic aid in the detection of glaucoma.
    Device Description
    The AccuMap comprises the following components: - Two monitors, one for displaying the stimulus and the other for displaying the input to and output from the OPERA software. - A computer with specialized hardware and software. - A four-channel medical amplifier. - A specially designed headset. - A hand-held button used by the patient for responding. The design of the AccuMap means that all the components fit into one compact, mobile unit.
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