HALA'TUS 1 OXYGENATOR

HALA'TUS 1 OXYGENATOR is an FDA 510(k)-cleared medical device (K903504) manufactured by The Henry G. Dietz Co., 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 January 27, 1991. Regulation: 8.