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

    PHONAK TINNITUS BALANCE

    K Number: K123450 · Decision Feb 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    76
    Applicant Total
    2
    Review Days
    94

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    Basic Information

    Device Name
    PHONAK TINNITUS BALANCE
    K Number
    K123450
    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
    Phonak, LLC
    Date Received
    November 9, 2012
    Decision Date
    February 11, 2013
    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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    Other Clearances by Phonak, LLC

    K Number Device Name
    K130790 LYRIC2