ECHOCARDIOGRAPHY SYS., MODEL 3830

ECHOCARDIOGRAPHY SYS., MODEL 3830 is an FDA 510(k)-cleared medical device (K770755) manufactured by Honeywell, 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 May 8, 1977. Regulation: 8.