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    K Number
    K221963
    Device Name
    Cumulus Functional Neurophysiology Platform
    Manufacturer
    Cumulus Neuroscience Limited
    Date Cleared
    2023-04-27

    (296 days)

    Product Code
    GWQ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cumulus Neuroscience Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cumulus Functional Neurophysiology Platform is intended for the acquisition, display and storage of electroencephalograph (EEG) obtained by placing electrodes on the head of adults and adolescent patients. The EEG signals are time-stamped. The system can be used in the patient's home or a health care facility.
    Device Description
    The Cumulus Functional Neurophysiology Platform is comprised of the Cumulus Headset which records EEG signals that are time-stamped. The Cumulus software application runs on a mobile device running android software. The software has graphical user interface that provides guidance to the user to place the headset correctly. The EEG data is received from the headset via Bluetooth. The data received is synchronised and timestamped between the headset and app. The Cumulus Medical Device Hub provides the user interface for health care professionals to view, download and review data from the recordings. The Platform components are: • Cumulus EEG Headset with embedded software, which includes: • An adjustable shell into which 16 Ag/AgCl EEG conductive sensors are attached. • A zippered pocket for holding the detachable electronics. • Interface buttons, LEDs, micro USB socket. • Plastic-encased 'Puck' electronics. • Cumulus Mobile device with installed Cumulus Mobile App. • Disposable mastoid sticky sensors • Earphones • Device stand • Headset and mobile device chargers Patient contacting materials are biocompatible, commercially sourced and are used in the headset without modifications. The device and accessories are not sterile, nor intended to be sterilized.
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