REXTON HS(HEARING SYSTEM)

REXTON HS(HEARING SYSTEM) is an FDA 510(k)-cleared medical device (K791548) manufactured by Argosy Intl. (Usa), Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 27, 1979. Regulation: 8.