510(k) K203273

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) by Echosens — Product Code IYO

K203273 is an FDA 510(k) premarket notification submitted by Echosens for the device "FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)". The FDA issued a decision of Substantially Equivalent on Mar 25, 2021. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Echosens has 10 other 510(k) clearances on record.