510(k) K013219

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

K013219 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "PROTOCO2L INSUFFLATOR MODEL 6400". The FDA issued a decision of Substantially Equivalent on February 19, 2002. 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.