510(k) K053008

E-Z-EM ENDOSCOPIC CO2 REGULATOR by E-Z-Em, Inc. — Product Code FCX

K053008 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "E-Z-EM ENDOSCOPIC CO2 REGULATOR". The FDA issued a decision of Substantially Equivalent on December 27, 2005. 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.