510(k) K191307

Palm Bladder Scanner - PBSV5.1 by Mianyang Meike Electronic Equipment Co., Ltd. — Product Code IYO

K191307 is an FDA 510(k) premarket notification submitted by Mianyang Meike Electronic Equipment Co., Ltd. for the device "Palm Bladder Scanner - PBSV5.1". The FDA issued a decision of Substantially Equivalent on Jun 5, 2019. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Mianyang Meike Electronic Equipment Co., Ltd. has 2 other 510(k) clearances on record.