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510(k) Data Aggregation

    K Number
    K963330
    Device Name
    URODYNAMIC ANALYSIS MODULE
    Manufacturer
    SYNECTICS MEDICAL, INC.
    Date Cleared
    1997-04-03

    (223 days)

    Product Code
    FAP
    Regulation Number
    876.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNECTICS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Urodynamic Analysis Module is a software program that has been designed to analyze pressure, volume and flow data recorded from the urological tract in pediatric and adult populations. The Urodynamic Analysis Module includes the following analyses: Uroflow analysis. Cystometry analysis, Pressure/flow voiding analysis, Urethral Pressure Profile. The program is to be used on a personal computer analyzing patient data in the hospital environment under supervision of a trained physiclan. The analyzed data can be viewed on the computer screen or printed out on a separate paper.
    Device Description
    The Polygram Software for Windows (KD46322) 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 Urodynamic Analysis Module to the Polygram Software for Windows, the user can also have all the pressure, flow and volume 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; Urodynamic tracing; analyses (as specified below); and physician signature section.
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    K Number
    K961070
    Device Name
    ESOPHAGEAL MANOMETRY ANALYSIS MODULE
    Manufacturer
    SYNECTICS MEDICAL, INC.
    Date Cleared
    1996-06-11

    (85 days)

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

    SYNECTICS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Esophageal Manometry Analysis Module has been designed to analyze intragastroesophageal pressure data throughout the gastrointestinal tract. The Esophageal Manometry Analysis Module has been designed for the same intended use (analyze intragastroesophageal pH data) in both pediatric and adult populations. The product is to be used on patients in the hospital environment under supervision of a trained physician.
    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 are minimum value, maximum value, and the length of the selection. By adding the Esophageal Manometry 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.
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