510(k) K081921

GE VIVID E9 ULTRASOUND by General Electric Co. — Product Code IYN

K081921 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "GE VIVID E9 ULTRASOUND". The FDA issued a decision of Substantially Equivalent on August 6, 2008. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. General Electric Co. has at least 10 other 510(k) clearances on record.