MARK II/MARK III MANOMETRIC PERFUSION PUMP

MARK II/MARK III MANOMETRIC PERFUSION PUMP is an FDA 510(k)-cleared medical device (K013154) manufactured by Dentsleeve Pty., Ltd.. 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 October 18, 2001. Regulation: 8.