BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.

    K Number: K052562 · Decision Dec 23, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    4
    Review Days
    95

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    Basic Information

    Device Name
    ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
    K Number
    K052562
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Interacoustics AS
    Date Received
    September 19, 2005
    Decision Date
    December 23, 2005
    Product Code
    EWO
    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
    EWO Audiometer

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    Other Clearances by Interacoustics AS

    K Number Device Name
    K090406 EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE
    K083861 TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE
    K043219 AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS