MCOMPASS ANORECTAL MANOMETRY SYSTEM

MCOMPASS ANORECTAL MANOMETRY SYSTEM is an FDA 510(k)-cleared medical device (K120088) manufactured by Medspira, LLC. 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 March 28, 2012. Regulation: 8.