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510(k) Data Aggregation

    K Number
    K050702
    Device Name
    NEUROSYSTEMS 1TM MONITOR
    Manufacturer
    NEUROSYSTEMS LLC
    Date Cleared
    2005-05-17

    (60 days)

    Product Code
    GWM
    Regulation Number
    882.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROSYSTEMS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeuroSystems 1™ monitor has been designed for use by a qualified neurosurgeon to display variables from existing legally marketed primary measuring devices used to monitor neurosurgical patients. The variables displayed by the NeuroSystems 1™ monitor include intracranial pressure, cerebral blood flow, brain tissue oxygen, brain temperature and pH, carbon dioxide and arterial blood pressure, and these are presented both continuously and as trends in these variables, and in the form of relationship graphs. The presentation of both measured variables and the relationships between them is intended as an adjunct to the information provided by existing primary monitors, and the NeuroSystems 1™ monitor should not be used alone as the sole basis for decisions as to diagnosis or therapy.
    Device Description
    The NeuroSystems 1TM monitor is a secondary display system that collects together on a single large color display screen all of the measured variables relevant to the multi-modality monitoring of the patient in a neurosurgical intensive care unit. The NeuroSystems 17M monitor has inputs to receive analog data from primary monitors used in the measurement of intracranial pressure, cerebral blood flow, brain tissue oxygen, brain temperature and pH, carbon dioxide and arterial blood pressure. The monitor can also derive the cerebral perfusion pressure. The NeuroSystems 17M monitor displays the measured and derived variables in digital and analog trace form, and can store and display trends over periods of 1,2,8 or 24 hours. The system also facilitates the display of the interrelationships between the measured and derived variables. This allows the approximation of Cerebral Autoregulation, Vasoreactivity and O2 Metabolic Index.
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