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

    TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE

    K Number: K083861 · Decision Apr 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    69
    Applicant Total
    4
    Review Days
    106

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    Basic Information

    Device Name
    TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE
    K Number
    K083861
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1090
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Interacoustics AS
    Date Received
    December 24, 2008
    Decision Date
    April 9, 2009
    Product Code
    ETY
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ETY Tester, Auditory Impedance

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    Other Clearances by Interacoustics AS

    K Number Device Name
    K090406 EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE
    K052562 ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
    K043219 AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS