PROGNOST ES, MODEL 0302 0000

PROGNOST ES, MODEL 0302 0000 is an FDA 510(k)-cleared medical device (K011290) manufactured by Xmar Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 29, 2001. Regulation: 8.