BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VOCALTECH VOCAL FEEDBACK DEVICE

    K Number: K871590 · Decision Oct 6, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    165

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    Basic Information

    Device Name
    VOCALTECH VOCAL FEEDBACK DEVICE
    K Number
    K871590
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.5840
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Vocaltech C/O Hogan & Hartson
    Date Received
    April 24, 1987
    Decision Date
    October 6, 1987
    Product Code
    KTH
    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
    KTH Device, Anti-Stammering

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