ACCESSORY TO GENESIS III (GCFM)

ACCESSORY TO GENESIS III (GCFM) is an FDA 510(k)-cleared medical device (K913209) 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 May 14, 1992. Regulation: 8.