510(k) K043524

ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 by B-K Medical A/S — Product Code IYN

K043524 is an FDA 510(k) premarket notification submitted by B-K Medical A/S for the device "ULTRASOUND SCANNER PRO FOCUS, MODEL 2202". The FDA issued a decision of Substantially Equivalent on January 13, 2005. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. B-K Medical A/S has at least 6 other 510(k) clearances on record.