RESPIRGARD II, SPIROGARD

RESPIRGARD II, SPIROGARD is an FDA 510(k)-cleared medical device (K961838) manufactured by Marquest Medical Products, Inc.. 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 17, 1996. Regulation: 8.