BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR

BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR is an FDA 510(k)-cleared medical device (K132192) manufactured by Bracco Diagnostic, 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 February 13, 2014. Regulation: 8.