510(k) K003041

ULTRASOUND SCANNER TYPE 2101 by B-K Medical A/S — Product Code IYO

K003041 is an FDA 510(k) premarket notification submitted by B-K Medical A/S for the device "ULTRASOUND SCANNER TYPE 2101". The FDA issued a decision of Substantially Equivalent on February 7, 2001. 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 A/S has at least 6 other 510(k) clearances on record.