510(k) K223832

Vivid S60N, Vivid S70N by Ge Medical System Ultrasound And Primary Care Diagnostics — Product Code IYN

K223832 is an FDA 510(k) premarket notification submitted by Ge Medical System Ultrasound And Primary Care Diagnostics for the device "Vivid S60N, Vivid S70N". The FDA issued a decision of Substantially Equivalent on Feb 16, 2023. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550.