SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS

SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS is an FDA 510(k)-cleared medical device (K802687) manufactured by Intelligent Software Systems, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 3, 1981. Regulation: 8.