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510(k) Data Aggregation

    K Number
    K162681
    Device Name
    Enobio Wireless EEG
    Date Cleared
    2017-06-02

    (249 days)

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

    Neuroelectrics Barcelona S.L.U.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ENOBIO is an EEG portable monitoring device of 8, 20, 32 channels intended for the use in clinical patient monitoring for use in hospitals and other medical environments. The Enobio is intended to acquire, store, transmit and display electrophysiological signals in wireless mode as an aid in diagnostics. The system digitizes analogue EEG signals collected by a cap with electrodes, amplifies them, and uses WiFi connectivity to transmit the EEG data to a dedicated host computer with the software. This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.
    Device Description
    The Neuroelectrics device, Enobio Wireless EEG, performs electroencephalographic measurements with non-invasive technology. Enobio is a wireless, battery-operated and portable electrophysiology sensor system for the recording of the electroencephalogram (EEG). It has been designed for use in a clinical environment or hospital.. Enobio use must be controlled by specialized medical personnel able to guarantee the correct recording. ENOBIO WIRELESS EEG, consists of three models designated as the 8, 20 and 32 channels. ENOBIO WIRELESS EEG has a sampling rate of 500 SPS, it works in a bandwidth from 0 to 125Hz (DC coupled) and it provides a resolution of 24 bits - 0.05μV. Enobio is capable of acquiring a variety of electrophysiological signals. These signals include EEG, EOG, ECG and EMG. The Enobio system is primarily made up of the following three items: - Necbox (amplifier, transmitter and control box), - the neoprene cap with the electrodes and - the NIC software. The Necbox, which has a data amplifier, connects directly via Wi-Fi to the Neuroelectrics Instrument Controller (NIC) software running on a computer. The EEG data is streamed through the standard Wi-Fi band, and the standard Wi-Fi operating distance range is 10 meters. In all situations the amplifiers store a copy of the data locally to allow for data back-up. This amplifier provides storage and subsequent transmission of data that is not transferred live when the amplifier is in out of range situations.
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