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510(k) Data Aggregation

    K Number
    K961346
    Device Name
    PH ANALYSIS MODULE
    Manufacturer
    SYNECTICS-DANTEC
    Date Cleared
    1997-01-29

    (320 days)

    Product Code
    FFT
    Regulation Number
    876.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNECTICS-DANTEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pH Analysis Module is a software program that has been designed to analyze intragastroesophageal pH data recorded from the gastrointestinal tract in pediatric and adult populations. The program is to be used on a personal computer analyzing patient data in the hospital environment under supervision of a trained physician. The analyzed data can be viewed on the computer screen or printed out on a separate paper.
    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 min and max values, length of selection. By adding the pH Analysis Module to the Polygram Software for Windows, the user can also have all the intragastroesophageal pH data analyzed (data recorded from the gastrointestinal tract in pediatric and adult population). The analysis report includes sections such as patient demographics; intepretation and comment (for user to insert); procedure summary; pH tracing; period table including number such as duration of recording, number of periods of interest, time where pH was below certain threshold value, symptom correlation, scoring; physician signature section. The analysis report can then serve as a part of the physician's diagnosis and post treatment evaluation.
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