ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM

ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM is an FDA 510(k)-cleared medical device (K963064) manufactured by Laborie Medical Tech 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 June 4, 1997. Regulation: 8.