510(k) K052039

GE OEC ALTITUDE by Ge Oec Medical Systems — Product Code IZI

K052039 is an FDA 510(k) premarket notification submitted by Ge Oec Medical Systems for the device "GE OEC ALTITUDE". The FDA issued a decision of Substantially Equivalent on August 11, 2005. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Ge Oec Medical Systems has at least 10 other 510(k) clearances on record.