510(k) K123047

BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET by Bracco Diagnostic, Inc. — Product Code FCX

K123047 is an FDA 510(k) premarket notification submitted by Bracco Diagnostic, Inc. for the device "BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET". The FDA issued a decision of Substantially Equivalent on August 6, 2013. 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.