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

    NERVE STIMULATOR, MOLEL NO. FB-800

    K Number: K770987 · Decision Jun 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    60
    Applicant Total
    5
    Review Days
    14

    Basic Information

    Device Name
    NERVE STIMULATOR, MOLEL NO. FB-800
    K Number
    K770987
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5810
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    OUTPUT, INC.
    Date Received
    May 31, 1977
    Decision Date
    June 14, 1977
    Product Code
    GZI
    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
    GZI Stimulator, Neuromuscular, External Functional

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