510(k) K132335

ULTRASOUND SCANNER FLEX FOCUS 1202 by B-K Medical Aps — Product Code IYN

K132335 is an FDA 510(k) premarket notification submitted by B-K Medical Aps for the device "ULTRASOUND SCANNER FLEX FOCUS 1202". The FDA issued a decision of Substantially Equivalent on Jan 10, 2014. 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.