510(k) K011160

E-Z EM PERCUPUMP 2001 CT INJECTOR by E-Z-Em, Inc. — Product Code JAK

K011160 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "E-Z EM PERCUPUMP 2001 CT INJECTOR". The FDA issued a decision of Substantially Equivalent on May 16, 2001. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. E-Z-Em, Inc. has at least 10 other 510(k) clearances on record.