510(k) K091164

GE VENUE 40, MODEL 5324338 by Ge Medical Systems China Co., Ltd. — Product Code IYN

K091164 is an FDA 510(k) premarket notification submitted by Ge Medical Systems China Co., Ltd. for the device "GE VENUE 40, MODEL 5324338". The FDA issued a decision of Substantially Equivalent on May 5, 2009. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Ge Medical Systems China Co., Ltd. has at least 10 other 510(k) clearances on record.