510(k) K140380

OPERA SWING by General Medical Merate S.P.A — Product Code JAA

K140380 is an FDA 510(k) premarket notification submitted by General Medical Merate S.P.A for the device "OPERA SWING". The FDA issued a decision of Substantially Equivalent on September 26, 2014. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. General Medical Merate S.P.A has at least 6 other 510(k) clearances on record.