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510(k) Data Aggregation

    K Number
    K242832
    Device Name
    NExT Station; NExT Station Advanced
    Manufacturer
    EB Neuro S.p.A.
    Date Cleared
    2024-12-12

    (84 days)

    Product Code
    GWL, GWE, GWF, GWJ, IKN, OLT
    Regulation Number
    882.1835
    Why did this record match?
    Applicant Name (Manufacturer) :

    EB Neuro S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NExT Station and NExT Station Advanced are physiological signal amplifiers intended to be used during Electromyography (EMG) and Evoked Potential (EP) exams to acquire bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The devices include Galileo NT Line software to record and display acquired data to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles. The devices include an electrical stimulator, an auditory stimulator, and a photic stimulator as accessories that may optionally be used in evoked response analysis.
    Device Description
    EMG Family devices (NEXT Station and NEXT Station Advanced) are capable of detecting electrical signals produced by the central and peripheral nervous systems and by striated muscles. In connection with a PC, where the Galileo NT Line software is installed, they allow to perform both spontaneous and evoked electromyographic activity easily and in all their phases. Their fields of application are Electromyography (EMG) and Evoked Potentials (EP). EB Neuro EMG Family devices include all the elements necessary for the acquisition of neurographic signals, for their analog-digital conversion and pre-processing, for audio monitoring, for the delivery of electrical, acoustic and visual stimulation. The functions of user interface, presentation, post-processing, storage, signals archiving and printing and data extracted from them are managed by a PC installed with the Galileo NT Line software. Two versions are available depending on the support where the Medical Device is placed: - “Mobile” is a mobile device placed on a cart, powered at 115V by Isolation Transformer and connected with a PC with Galileo NT Line medical device software running on the PC. - “Portable” is a portable device placed on a desk, powered at 115V by medical power supply and connected with a PC with Galileo NT Line medical device software running on a Laptop PC.
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    K Number
    K242305
    Device Name
    BE Plus PRO, Neurotravel LIGHT
    Manufacturer
    EB Neuro S.p.A.
    Date Cleared
    2024-09-04

    (30 days)

    Product Code
    GWL, GWQ, OLT, OLV
    Regulation Number
    882.1835
    Why did this record match?
    Applicant Name (Manufacturer) :

    EB Neuro S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BE Plus PRO and Neurotravel LIGHT are intended to be used for Electroencephalography (EEG) and Polysomnography (PSG) exams, in combination with the Galileo NT Line software, for human beings to assist the user in diagnosis and monitoring of disorders of the central and peripheral nervous system and muscles.
    Device Description
    EEG Family devices (BE plus PRO and Neurotravel LIGHT) are active medical devices composed of various parts necessary to allow the achievement of their intended use. All these parts are intended to be interconnected to achieve the specified medical purpose. EEG Family devices can be used in patients, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions. EEG Family devices are capable of acquiring the bioelectric signal generated by the electrical potentials of the neurons of the cerebral cortex, by means of suitable signal, stimulus electrodes. This signal, of the order of a first and then, filtered to claim it of noise and offset. It is then digitized by a high-resolution analog-to-digital converter at a certain sampling rate. The signals acquired and converted into digital format are transferred to a Host PC through a special serial communication with a dedicated protocol and then can be processed by the Galileo NT software to complete the intended use. The software part allows the implementation of many specific functions of visualization, measurement, processing and storage of brain signals, acquired by the acquisition unit, based on the clinical area of interest. EEG Family devices are offered in the following two configurations: - Mobile: All components are mounted on a mobile trolley. - Portable: All components are mounted on a stationary desktop.
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