510(k) K930581

E-Z-FLATE by E-Z-Em, Inc. — Product Code FCX

K930581 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "E-Z-FLATE". The FDA issued a decision of Substantially Equivalent on July 1, 1994. 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.