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

    LINGRAPHICA VISUAL LANGUAGE PROSTHESIS

    K Number: K905576 · Decision Dec 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    37
    Applicant Total
    1
    Review Days
    19

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    Basic Information

    Device Name
    LINGRAPHICA VISUAL LANGUAGE PROSTHESIS
    K Number
    K905576
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3710
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Tolfa Corp.
    Date Received
    December 12, 1990
    Decision Date
    December 31, 1990
    Product Code
    ILQ
    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
    ILQ System, Communication, Powered

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