BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID

    K Number: K011472 · Decision Aug 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    67
    Applicant Total
    11
    Review Days
    88

    Basic Information

    Device Name
    POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID
    K Number
    K011472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1725
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
    Date Received
    May 14, 2001
    Decision Date
    August 10, 2001
    Product Code
    FFX
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FFX System, Gastrointestinal Motility (Electrical)

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    Other Clearances by MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S

    K Number Device Name
    K014269 POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102
    K011471 BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER
    K002992 DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431
    K010130 POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
    K000386 POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
    K992715 NEURO URODYNAMIC SUITE, MODEL 9032E0101
    K992713 POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101
    K991389 ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
    K990375 DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
    K981733 DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111
    Search all 11 clearances from MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S →