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

    KATALAVOX VOICE-ACTIVATED SWITCHING DEVICE

    K Number: K855086 · Decision Apr 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    1
    Review Days
    105

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    Basic Information

    Device Name
    KATALAVOX VOICE-ACTIVATED SWITCHING DEVICE
    K Number
    K855086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Kempf Co.
    Date Received
    December 20, 1985
    Decision Date
    April 4, 1986
    Product Code
    ITI
    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
    ITI Wheelchair, Powered

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