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

    SPEECH TEACHER

    K Number: K840112 · Decision Mar 22, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    73

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    Basic Information

    Device Name
    SPEECH TEACHER
    K Number
    K840112
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3700
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Joseph A. Resnick
    Date Received
    January 9, 1984
    Decision Date
    March 22, 1984
    Product Code
    ILP
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ILP System, Communication, Non-Powered

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