
Neurowave Systems, Inc.
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NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 is an FDA 510(k)-cleared medical device (K092477) manufactured by Neurowave Systems, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 28, 2010. Regulation: 8.