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Acutronic Medical Systems AG
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MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES is an FDA 510(k)-cleared medical device (K012691) 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 December 19, 2002. Regulation: 8.