INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG

INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG is an FDA 510(k)-cleared medical device (K981308) manufactured by International Respiratory 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 July 5, 1998. Regulation: 8.