GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN

GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN is an FDA 510(k)-cleared medical device (K873032) manufactured by Biosound, 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 17, 1988. Regulation: 8.