510(k) K152052

Ultrasound Scanner System bk2300 by Bk Medical Aps — Product Code IYN

K152052 is an FDA 510(k) premarket notification submitted by Bk Medical Aps for the device "Ultrasound Scanner System bk2300". The FDA issued a decision of Substantially Equivalent on September 16, 2015. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Bk Medical Aps has at least 8 other 510(k) clearances on record.