510(k) K132346

ULTRASOUND SCANNER PRO FOCUS 2202 by B-K Medical Aps — Product Code IYO

K132346 is an FDA 510(k) premarket notification submitted by B-K Medical Aps for the device "ULTRASOUND SCANNER PRO FOCUS 2202". The FDA issued a decision of Substantially Equivalent on Jan 10, 2014. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. B-K Medical Aps has 10 other 510(k) clearances on record.