MOBIMED SYSTEM, (PEGASUS AND POLARIS)

MOBIMED SYSTEM, (PEGASUS AND POLARIS) is an FDA 510(k)-cleared medical device (K973318) manufactured by Ortivus Us, 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 February 18, 1998. Regulation: 8.