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510(k) Data Aggregation

    K Number
    K151576
    Device Name
    Neon EEG
    Manufacturer
    Incereb Ltd
    Date Cleared
    2015-09-29

    (110 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    Incereb Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NEON EEG is intended to be applied directly to the patient's scalp to enable recordings of electrophysiological signals (such as EEG) on infants from birth. The NEON EEG is indicated for single use only and should be replaced after 12 hours of use. The NEON EEG is not indicated for use with electro stimulation equipment.
    Device Description
    The NEON EEG consists of an array of pre-gelled electrodes that are sized to fit an infant's scalp. The electrodes are screen-printed in Ag/AgCl ink on a flexible polyester substrate and are pre-gelled with industry-standard electrode paste. The electrode array substrate has a thin layer of inert foam. The electrode array connects to a monitoring machine by an interface cable with medically-recognized safety end fittings ("touch proof" or "D type"). The safety connector is connected to the electrically and patient-isolated pre-amplifier input of a neuro-diagnostic or neuro-monitoring equipment. The NEON electrode array is sized to fit new-born infants and has a reduced lead set of 5 pairs of electrodes, plus a Ground and Reference. The positioning of the electrodes is based upon the principles of the 10-20 placement system, with individual electrodes labeled with their 10-20 nomenclature. The shape of the array is designed to allow access to the scalp, co-exist with other monitoring requirements, and allow free circulation of air. An industry-standard EEG electrolyte gel is supplied to allow optional application on individual electrodes sites.
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