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

    CUSTOMIZED SOUND THERAPY (CST)

    K Number: K070599 · Decision Jul 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    76
    Applicant Total
    1
    Review Days
    133

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    Basic Information

    Device Name
    CUSTOMIZED SOUND THERAPY (CST)
    K Number
    K070599
    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
    Tinnitus Otosound Products, LLC
    Date Received
    March 2, 2007
    Decision Date
    July 13, 2007
    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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