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

    VIGILANT EEG MONITOR MODEL VIGILANT 2.0

    K Number: K101386 · Decision Jul 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    188
    Applicant Total
    5
    Review Days
    73

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    Basic Information

    Device Name
    VIGILANT EEG MONITOR MODEL VIGILANT 2.0
    K Number
    K101386
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Infinite Biomedical Technologies, LLC
    Date Received
    May 18, 2010
    Decision Date
    July 30, 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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    Other Clearances by Infinite Biomedical Technologies, LLC

    K Number Device Name
    K240884 Glide (91000-GL-X)
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    K173571 Element System with IBT Electrodes
    K091963 VIGILANT EEG MONITOR, VIGILANT 2.0