ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1

ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 is an FDA 510(k)-cleared medical device (K082056) manufactured by Life-Tech, Inc.. 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 November 6, 2008. Regulation: 8.