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

    COMPANION SPEECH AID, MODEL 432

    K Number: K910796 · Decision Mar 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    37
    Applicant Total
    2
    Review Days
    9

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    Basic Information

    Device Name
    COMPANION SPEECH AID, MODEL 432
    K Number
    K910796
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3710
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Companion Products Intl.
    Date Received
    February 26, 1991
    Decision Date
    March 7, 1991
    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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    Other Clearances by Companion Products Intl.

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    K910819 COMPANION SPEECH AID, MODEL 160