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    K Number
    K062362
    Device Name
    SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS
    Manufacturer
    SARMED SRL
    Date Cleared
    2007-04-13

    (242 days)

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

    SARMED SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters are intended for Manometry analysis of Gastro-Intestinal and Ano-Rectal Tract. The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters are indicated for patients where Gastro-Intestinal and Ano-Rectal tracts pressure measurements are required, such as for detection of GI tract disorders. The products are to be used by a trained physician.
    Device Description
    The SarMed Single Use Esophageal Manometry and Ano-Rectal Manometry Catheters are available in some different configurations, respect to number of lumen and number of tubes. They are designed to be connected to a manometric infusion pump and allow, by the way of a defined number of holes, the measurement of pressure on the Gastro-Intestinal and Ano-Rectal Tract.
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