Enobio Dx

Device typeElectroencephalographic monitoring system: An electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features.

FDA categoryAmplifier, Physiological Signal, Full-Montage Standard Electroencephalograph

Device ID18436612823024

AvailabilityPrescription

MRI safetyMR Unsafe

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Emailsupport@neuroelectrics.com