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510(k) Data Aggregation
K Number
K050702Device Name
NEUROSYSTEMS 1TM MONITOR
Manufacturer
NEUROSYSTEMS LLC
Date Cleared
2005-05-17
(60 days)
Product Code
GWM
Regulation Number
882.1620Why 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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