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

    TINNITUS RX

    K Number: K031624 · Decision Jul 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    76
    Applicant Total
    2
    Review Days
    62

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    Basic Information

    Device Name
    TINNITUS RX
    K Number
    K031624
    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
    Tinnitus Control, Inc.
    Date Received
    May 23, 2003
    Decision Date
    July 24, 2003
    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 Tinnitus Control, Inc.

    K Number Device Name
    K061111 TINNITUS PHASE-OUT