THERA-MIST HUMIDIFIER

THERA-MIST HUMIDIFIER is an FDA 510(k)-cleared medical device (K894000) manufactured by Pegasus Research 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 August 27, 1989. Regulation: 8.