TRIPTER X-1 COMPACT DUET

TRIPTER X-1 COMPACT DUET is an FDA 510(k)-cleared medical device (K023535) manufactured by Direx Systems Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 16, 2003. Regulation: 8.