SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM

SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM is an FDA 510(k)-cleared medical device (K994096) manufactured by Sonosite,Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 19, 1999. Regulation: 8.