SIEMENS INFINITY GATEWAY SUITE, MODEL VF2

SIEMENS INFINITY GATEWAY SUITE, MODEL VF2 is an FDA 510(k)-cleared medical device (K030657) manufactured by Siemens Medical Solutions. 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 20, 2003. Regulation: 8.