510(k) K160343

SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner by Beijing East Whale Imaging Technology Co., Ltd. — Product Code IYN

K160343 is an FDA 510(k) premarket notification submitted by Beijing East Whale Imaging Technology Co., Ltd. for the device "SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner". The FDA issued a decision of Substantially Equivalent on April 7, 2016. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Beijing East Whale Imaging Technology Co., Ltd. has at least 5 other 510(k) clearances on record.