510(k) K231764

Ultrasound System 1300 by Bk Medical Aps — Product Code IYN

K231764 is an FDA 510(k) premarket notification submitted by Bk Medical Aps for the device "Ultrasound System 1300". The FDA issued a decision of Substantially Equivalent on October 23, 2023. 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.