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510(k) Data Aggregation

    K Number
    K213273
    Device Name
    Brain Anesthesia Response Monitor (Bar Monitor)
    Manufacturer
    Cortical Dynamics Ltd
    Date Cleared
    2023-09-01

    (701 days)

    Product Code
    OLW, GXY, OMC
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cortical Dynamics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BAR Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system displays a patient's EEG and Composite Cortical State (CCS), a proprietary computed EEG index related to the effect of certain anesthetic or hypnotic agents include inhalation agents and propofol in combination with opioids. The BAR Monitor is intended to assist medical professionals monitor adult patients (22 to 65 years of age) in the operating room (OR) and clinical research laboratory.
    Device Description
    The Brain Anaesthesia Response Monitor (BARM) is a device designed to non-invasively monitor brain function in response to anesthetic agents including inhalation agents in the operating room (OR) and clinical research laboratory. The system consists of the following three components: - . Brain Anaesthesia Response (BAR) Terminal - Provides a user interface to control the DAM, set configuration parameters and display the DAM output for users. - . Data Acquisition Module (DAM) - Collects and processes the signal sent by the electrodes and calculates the Composite Cortical State (CCS) index and outputs the information to the BAR Terminal. - Disposable cutaneous electrode sensor- The electrodes collect Brain electrical activity (EEG) signals and transfers them to the DAM. The electrodes are made from pre-gelled Ag-AgCl. The electrodes are connected with patient leads which is plugged into the DAM. The electrodes are applied to the patients' forehead and behind the ear and is held in place via biocompatible adhesives.
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