MYSTIQUE ULTRASONIC NEBULIZER

MYSTIQUE ULTRASONIC NEBULIZER is an FDA 510(k)-cleared medical device (K983002) manufactured by Airsep Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 15, 1998. Regulation: 8.