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

    AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS

    K Number: K043219 · Decision Feb 4, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    4
    Review Days
    74

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    Basic Information

    Device Name
    AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
    K Number
    K043219
    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
    November 22, 2004
    Decision Date
    February 4, 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

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