510(k) K092164

TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA by Shenzhen Delicate Electronics Co., Ltd. — Product Code OQQ

K092164 is an FDA 510(k) premarket notification submitted by Shenzhen Delicate Electronics Co., Ltd. for the device "TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA". The FDA issued a decision of Substantially Equivalent on May 13, 2010. The device falls under product code OQQ (Diagnostic Ultrasonic Transducer, Robotic), a Class II device regulated under 21 CFR 892.1570. Shenzhen Delicate Electronics Co., Ltd. has at least 1 other 510(k) clearance on record.