510(k) K030854

PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 by E-Z-Em, Inc. — Product Code FCX

K030854 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400". The FDA issued a decision of Substantially Equivalent on April 16, 2003. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500. E-Z-Em, Inc. has at least 10 other 510(k) clearances on record.