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510(k) Data Aggregation

    K Number
    K221563
    Device Name
    Neurosteer EEG Recorder
    Manufacturer
    Neurosteer Inc.
    Date Cleared
    2022-10-24

    (146 days)

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

    Neurosteer Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neurosteer EEG Recorder is intended to record and store EEG signals, and to present the EEG signals in visual formats in real time. The visuals assist trained medical staff to make neurological diagnoses. The EEG Recorder does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The EEG Recorder is intended to be used in a professional healthcare facility environment.
    Device Description
    The Neurosteer brain monitoring platform is a portable single-channel EEG that measures and records electrical activity of the brain. An adhesive electrode strip is affixed to the subject's forehead to capture the brain activity signal. The strip is attached to a sensing device that transmits the signal via low-energy Bluetooth (BLE) to a local brain activity monitor. The brain activity monitor provides technical status indicators about the recording (such as battery level, connection status, and electrode disconnection alert). It can also be used to provide auditory prompt sequences (using an external speaker) during monitoring. The signal is sent via a secure Internet connection to the cloud (either wireless Wi-Fi or physical Ethernet) where the data is stored according to HIPAA quidelines. Data processing performed in the cloud transforms the raw electrical brain activity signal into a display representation of the signal. When the Internet connection is available, both the raw and processed data can be viewed in real-time on the brain activity monitor and through the web portal. When the connection is not available, only the raw data can be viewed in real-time on the brain activity monitor.
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