510(k) K213689

Voluson P6, Voluson P8 by GE Healthcare — Product Code IYN

K213689 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "Voluson P6, Voluson P8". The FDA issued a decision of Substantially Equivalent on February 17, 2022. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. GE Healthcare has at least 10 other 510(k) clearances on record.