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510(k) Data Aggregation

    K Number
    K092625
    Device Name
    WAVESTATE NEUROMONITOR
    Manufacturer
    WAVESTATE INC
    Date Cleared
    2010-06-29

    (306 days)

    Product Code
    ORT, DEV, GWO
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAVESTATE INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wavestate Neuromonitor System is intended to collect, record, and store up to 24 channels of adult EEG data for up to 24 hours. The System also can perform a post review of adult EEG data and identify burst suppression pattern in the stored EEG. The device displays the mean interburst interval reviewed up to that time point and the probability that the displayed value is within +/- 2 seconds of the mean of the interburst intervals for the entire dataset for that patient. The Wavestate Neuromonitor System does not provide any diagnostic conclusion about the patient's condition to the user. The Wavestate Neuromonitor is to be used under the guidance and interpretation of a licensed medical practitioner.
    Device Description
    Wavestate, Inc. has created a new application for the TrackIt-2, an FDA-approved ambulatory EEG hardware unit manufactured by Lifelines, Ltd (UK). Our proprietary software analyzes EEG data files recorded with the TrackIt-2. Data are displayed on an Xplore touch-screen tablet computer using Microsoft Windows XP. Our application is used to quantify the inter-burst interval with 95% statistical confidence the duration of the interval within +/- 2 seconds. The Trackit-2 system is FDA approved. FDA-approved EEG electrodes will be bought separately by the end user.
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