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

    VIGILANT EEG MONITOR, VIGILANT 2.0

    K Number: K091963 · Decision Nov 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    53
    Applicant Total
    5
    Review Days
    128

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    Basic Information

    Device Name
    VIGILANT EEG MONITOR, VIGILANT 2.0
    K Number
    K091963
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Infinite Biomedical Technologies, LLC
    Date Received
    July 1, 2009
    Decision Date
    November 6, 2009
    Product Code
    OLT
    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
    OLT Non-Normalizing Quantitative Electroencephalograph Software

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