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510(k) Data Aggregation

    K Number
    K061908
    Device Name
    NICOLETONE SYSTEM V32 AMPLIFIER
    Manufacturer
    VIASYS NEUROCARE
    Date Cleared
    2006-11-06

    (124 days)

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

    VIASYS NEUROCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NicoletOne System V32 Amplifier is a stand alone electroencephalography (EEG) amplifier for the recording of electrical signals from the brain. An optional feature of pulse oximetery (SpO2) is available.
    Device Description
    The NicoletOne System V32 Amplifier is a stand alone EEG amplifier embodiment. The V32 Amplifier supports 32 channels of patient input. The EEG electrode interface (headbox) is integral to the amplifier. The NicoletOne System V32 Amplifier provides an electrophysiological amplifier variation for use with the NicoletOne System. An optional external passive headbox, the HB3, is available for use with the V32 Amplifier. An optional Original Equipment Manufacturer (OEM) supplied pulse oximeter can be provided as a signal input from the patient. The optional OEM pulse oximeter feature is supported by a NONIN XPOD pulse oximeter module and NONIN Pure light 8000X Series Pulse Oximeter Sensor. The V32 Amplifier has a system evaluation signal (calibration signal) to verify system signal pathways, electrode impedance display on the amplifier and uses an Ethernet connection to communicate to the NicoletOne System computer. No physiologic alarms are supported by the V32 Amplifier.
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