BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    NEUROLINK IP MODEL: PK1117

    K Number: K100683 · Decision Apr 9, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    186
    Applicant Total
    7
    Review Days
    30

    Basic Information

    Device Name
    NEUROLINK IP MODEL: PK1117
    K Number
    K100683
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    NATUS MEDICAL INCORPORATED
    Date Received
    March 10, 2010
    Decision Date
    April 9, 2010
    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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