510(k) K021049

OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM by Ge Oec Medical Systems — Product Code OWB

K021049 is an FDA 510(k) premarket notification submitted by Ge Oec Medical Systems for the device "OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 17, 2002. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Ge Oec Medical Systems has at least 10 other 510(k) clearances on record.