YES-NO VOICE BOX 7011

YES-NO VOICE BOX 7011 is an FDA 510(k)-cleared medical device (K901029) manufactured by Baylor Biomedical Services. 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 March 12, 1990. Regulation: 8.