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

    BODAI PATIENT COMMUNICATOR

    K Number: K812720 · Decision Nov 5, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    37
    Applicant Total
    7
    Review Days
    41

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    Basic Information

    Device Name
    BODAI PATIENT COMMUNICATOR
    K Number
    K812720
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3710
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Sontek Industries, Inc.
    Date Received
    September 25, 1981
    Decision Date
    November 5, 1981
    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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    K813324 BODAI SWIVEL Y
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