510(k) K932848

SIMULIX-MC CT EXTENSION by Oldelft Corp. of America — Product Code JAK

K932848 is an FDA 510(k) premarket notification submitted by Oldelft Corp. of America for the device "SIMULIX-MC CT EXTENSION". The FDA issued a decision of Substantially Equivalent on March 22, 1994. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Oldelft Corp. of America has at least 8 other 510(k) clearances on record.