BWMINI EEG, BWMINIHST, BWMINI PSG

BWMINI EEG, BWMINIHST, BWMINI PSG is an FDA 510(k)-cleared medical device (K131335) manufactured by Neurovirtual USA, 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 February 2, 2015. Regulation: 8.