IMASK, MODELS 100, 200 AND 300

IMASK, MODELS 100, 200 AND 300 is an FDA 510(k)-cleared medical device (K051559) manufactured by Vital Signs Colorado, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 7, 2005. Regulation: 8.