BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Nihon Kohden Wireless Input Unit WEE-1200

    K Number: K171124 · Decision Aug 25, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    188
    Applicant Total
    19
    Review Days
    130

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    Basic Information

    Device Name
    Nihon Kohden Wireless Input Unit WEE-1200
    K Number
    K171124
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nihon Kohden Corporation
    Date Received
    April 17, 2017
    Decision Date
    August 25, 2017
    Product Code
    GWQ
    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
    GWQ Full-Montage Standard Electroencephalograph

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