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

    SIBIS REMOTE ACTUATOR

    K Number: K871158 · Decision May 29, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    3
    Review Days
    66

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    Basic Information

    Device Name
    SIBIS REMOTE ACTUATOR
    K Number
    K871158
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5235
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Human Technologies, Inc.
    Date Received
    March 24, 1987
    Decision Date
    May 29, 1987
    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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