510(k) K100919

PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 by B-K Medical Aps — Product Code IYN

K100919 is an FDA 510(k) premarket notification submitted by B-K Medical Aps for the device "PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202". The FDA issued a decision of Substantially Equivalent on Dec 16, 2011. 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 Aps has 10 other 510(k) clearances on record.