510(k) K020876

ECHOSCAN, MODEL US-1800 by Nidek, Inc. — Product Code IYO

K020876 is an FDA 510(k) premarket notification submitted by Nidek, Inc. for the device "ECHOSCAN, MODEL US-1800". The FDA issued a decision of Substantially Equivalent on May 3, 2002. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Nidek, Inc. has at least 10 other 510(k) clearances on record.