510(k) K223448

Bladder Scanner Model: BVT02 by Xuzhou Kaixin Electronic Instrument Co., Ltd. — Product Code IYO

K223448 is an FDA 510(k) premarket notification submitted by Xuzhou Kaixin Electronic Instrument Co., Ltd. for the device "Bladder Scanner Model: BVT02". The FDA issued a decision of Substantially Equivalent on July 7, 2023. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560.