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

    PERIPHERAL NERVE STIMULATOR

    K Number: K760614 · Decision Nov 19, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    62
    Applicant Total
    5
    Review Days
    70

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    Basic Information

    Device Name
    PERIPHERAL NERVE STIMULATOR
    K Number
    K760614
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Output, Inc.
    Date Received
    September 10, 1976
    Decision Date
    November 19, 1976
    Product Code
    BXN
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BXN Stimulator, Nerve, Battery-Powered

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    Other Clearances by Output, Inc.

    K Number Device Name
    K800360 OUTPUT DIGITAL DISPLAY MODULE, MOD. 611
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