510(k) K132192

BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR by Bracco Diagnostic, Inc. — Product Code FCX

K132192 is an FDA 510(k) premarket notification submitted by Bracco Diagnostic, Inc. for the device "BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR". The FDA issued a decision of Substantially Equivalent on February 14, 2014. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500. Bracco Diagnostic, Inc. has at least 2 other 510(k) clearances on record.