INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION

INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION is an FDA 510(k)-cleared medical device (K093788) manufactured by Draeger Medical Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 7, 2010. Regulation: 8.