SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001

SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 is an FDA 510(k)-cleared medical device (K020641) manufactured by Worldwide Medical Technologies, LLC. 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 28, 2002. Regulation: 8.