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

    SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM

    K Number: K853178 · Decision Feb 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    48
    Review Days
    213

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    Basic Information

    Device Name
    SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM
    K Number
    K853178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5235
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Oxford Medilog, Inc.
    Date Received
    July 30, 1985
    Decision Date
    February 28, 1986
    Product Code
    HCB
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HCB Device, Aversive Conditioning

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