510(k) K111648

BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR by Bracco Diagnostic, Inc. — Product Code FCX

K111648 is an FDA 510(k) premarket notification submitted by Bracco Diagnostic, Inc. for the device "BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR". The FDA issued a decision of Substantially Equivalent on November 3, 2011. 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.