INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5

INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 is an FDA 510(k)-cleared medical device (K042656) 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 October 5, 2004. Regulation: 8.