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510(k) Data Aggregation
K Number
K092477Device Name
NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701
Manufacturer
NEUROWAVE SYSTEMS, INC.
Date Cleared
2010-10-29
(443 days)
Product Code
OMC
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
NEUROWAVE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeuroFAST Monitoring System, Model NF-201 is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the head. The NeuroFAST NF-201 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, ICU, ER, clinical settings and for clinical research. The NeuroFAST Monitor is to be used under the direction and interpretation of a licensed medical professional. The NeuroFAST Monitoring System, Model NF-201 does not provide any diagnostic conclusion about the patient's condition.
Device Description
The NeuroFAST Monitoring System, Model NF-201, is an EEG monitor that records and displays electroencephalograms (EEGs) obtained from noninvasive electrodes placed on a patient's head. The acquired EEG waveforms and processed EEG variables are continuously displayed by the system for interpretation by the licensed medical professional. The NeuroFAST Monitoring System, Model NF-201 has three main components: Display Module (DM-201), Patient Module (PM-201), and EasyPrep Sensor Kit (EK-701).
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