Infinity Acute Care System (IACS) Monitoring Solution

Infinity Acute Care System (IACS) Monitoring Solution is an FDA 510(k)-cleared medical device (K201764) 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 December 8, 2021. Regulation: 8.