510(k) K081154

ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 by B-K Medical Aps — Product Code IYO

K081154 is an FDA 510(k) premarket notification submitted by B-K Medical Aps for the device "ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202". The FDA issued a decision of Substantially Equivalent on May 23, 2008. 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.