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510(k) Data Aggregation

    K Number
    K192549
    Device Name
    Byteflies Kit
    Manufacturer
    Byteflies NV
    Date Cleared
    2020-06-22

    (279 days)

    Product Code
    OMC
    Regulation Number
    882.1400
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    Applicant Name (Manufacturer) :

    Byteflies NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Byteflies Kit is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, and transmit electrical activity of the brain by placing non-invasive electrodes on the head of patients. It acquires, records and transmits two channels of electroencephalogram (EEG) data. The medical use of data acquired by the Byteflies Kit is to be performed under the direction of a licensed medical professional. The Bytellies Kit does not provide any diagnostic conclusions about the patient's condition.
    Device Description
    The Byteflies Kit is a wearable medical device for continuous recording of non-invasive physiological signals in healthcare and home settings. The Byteflies Kit is intended to be configured by a trained healthcare professional and consists of 3 main components: 1. Sensor Dot: a biopotential wearable sensor that measures up to 2 bipolar channels of electroencephalography (EEG). It is powered by a rechargeable battery, can record data for up to 24 hours on a single charge, and has an LED indicator to report the operating status to the user. The sample-level EEG data is continuously stored on the Sensor Dot for later retrieval. 2. Sensor Patch: the interface between a Sensor Dot and non-invasive biopotential electrodes (not provided). It attaches magnetically to the Sensor Dot and has four DIN 42802 connectors. Two commercial disposable EEG electrodes per Sensor Patch channel are connected to the head of the subject in a reduced EEG montage. The Sensor Dot attached to the Sensor Patch is carried by the patient to continuously measure electrical brain activity. 3. Docking Station: up to 5 Sensor Dots can connect magnetically to the Docking Station and transfer recorded data to the Docking Station, while charging their batteries. The recorded sample-level EEG signals can then be downloaded from the Docking Station's Management Interface to a computer via a local WiFi network for long-term storage and further review by a healthcare professional. An AC/DC adapter with micro-USB cable supplies power to the Docking Station.
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