510(k) K102113

GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND by Ge Medical Systems China Co., Ltd. — Product Code IYN

K102113 is an FDA 510(k) premarket notification submitted by Ge Medical Systems China Co., Ltd. for the device "GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND". The FDA issued a decision of Substantially Equivalent on August 12, 2010. 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.