ERBEFLO 2 DISPOSABLE TUBING SYSTEM

ERBEFLO 2 DISPOSABLE TUBING SYSTEM is an FDA 510(k)-cleared medical device (K103235) manufactured by Erbe USA, 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 December 22, 2010. Regulation: 8.