MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES

MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES is an FDA 510(k)-cleared medical device (K012693) manufactured by Acutronic Medical Systems AG. 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 31, 2002. Regulation: 8.