510(k) K003986

ULTRASOUND SCANNER TYPE 2102 by B-K Medical A/S — Product Code IYN

K003986 is an FDA 510(k) premarket notification submitted by B-K Medical A/S for the device "ULTRASOUND SCANNER TYPE 2102". The FDA issued a decision of Substantially Equivalent on April 3, 2001. 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.