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

    EVOKED RESPONSE STIMULATORS

    K Number: K803226 · Decision Feb 5, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    22
    Applicant Total
    45
    Review Days
    48

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    Basic Information

    Device Name
    EVOKED RESPONSE STIMULATORS
    K Number
    K803226
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1845
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Bio-Logic Systems Corp.
    Date Received
    December 19, 1980
    Decision Date
    February 5, 1981
    Product Code
    GWK
    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
    GWK Conditioner, Signal, Physiological

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