VIGILANT EEG MONITOR, VIGILANT 2.0

VIGILANT EEG MONITOR, VIGILANT 2.0 is an FDA 510(k)-cleared medical device (K091963) manufactured by Infinite Biomedical Technologies, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 5, 2009. Regulation: 8.