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

    TINNITUS SOUNDSUPPORT

    K Number: K133308 · Decision Mar 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    76
    Applicant Total
    2
    Review Days
    141

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    Basic Information

    Device Name
    TINNITUS SOUNDSUPPORT
    K Number
    K133308
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3400
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oticon A/S
    Date Received
    October 28, 2013
    Decision Date
    March 18, 2014
    Product Code
    KLW
    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
    KLW Masker, Tinnitus

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