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510(k) Data Aggregation

    K Number
    K972439
    Device Name
    ANORECTAL MANOMETRY ANALYSIS MODULE
    Manufacturer
    MEDTRONIC-SYNECTICS
    Date Cleared
    1997-09-23

    (85 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC-SYNECTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anorectal Analysis Module is a software program that has been designed to analyze pressure data recorded from the lower gastrointestinal tract in pediatric and adult populations.
    Device Description
    The Polygram Software for Windows (K946322) was designed to record and handle/store physiological parameters. After a recording, the user is able to review the tracings on the computer screen and print the signal tracings or just parts of them. When reviewing the data on the computer screen, the user is able to mark certain segments and calculate certain parameters from the selected signal segments. These parameters include minimum and maximum values, length of selection. By adding the Anorectal Analysis Module to the Polygram Software for Windows, the user can also have all the pressure data analyzed in terms of physiological properties, comparison with normal values, etc. The analyzed data can thereafter be viewed on screen or printed out on a separate paper. The analysis report includes sections such as patient demographics; interpretation and comment (for user to insert); procedure summary; Anorectal tracing; analyses (as specified below); and physician signature section.
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