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

    BRAIN FUNCTION MAPPING OPTION FOR PATHF

    K Number: K843598 · Decision Apr 11, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    22
    Applicant Total
    26
    Review Days
    211

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    Basic Information

    Device Name
    BRAIN FUNCTION MAPPING OPTION FOR PATHF
    K Number
    K843598
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1845
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Nicolet Biomedical Instruments
    Date Received
    September 12, 1984
    Decision Date
    April 11, 1985
    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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