SAFECIRCUIT MANIFOLD/PULMONARY UNIT

SAFECIRCUIT MANIFOLD/PULMONARY UNIT is an FDA 510(k)-cleared medical device (K953269) manufactured by Advanced Warming Systems, 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 December 19, 1996. Regulation: 8.