MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM

MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM is an FDA 510(k)-cleared medical device (K091070) manufactured by Sierra Scientific Instruments, 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 May 18, 2009. Regulation: 8.