510(k) K914945

DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED by Bruel & Kjaer Industri A/S — Product Code IYO

K914945 is an FDA 510(k) premarket notification submitted by Bruel & Kjaer Industri A/S for the device "DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED". The FDA issued a decision of Substantially Equivalent on June 26, 1992. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Bruel & Kjaer Industri A/S has at least 3 other 510(k) clearances on record.