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510(k) Data Aggregation
K Number
K972439Device Name
ANORECTAL MANOMETRY ANALYSIS MODULE
Manufacturer
MEDTRONIC-SYNECTICS
Date Cleared
1997-09-23
(85 days)
Product Code
FFX
Regulation Number
876.1725Why 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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