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

    UNITRON TINNITUS MASKER FEATURE

    K Number: K130494 · Decision May 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    76
    Applicant Total
    1
    Review Days
    70

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    Basic Information

    Device Name
    UNITRON TINNITUS MASKER FEATURE
    K Number
    K130494
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    874.3400
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unitron Hearing
    Date Received
    February 26, 2013
    Decision Date
    May 7, 2013
    Product Code
    KLW
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    KLW Masker, Tinnitus

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