510(k) K033209

FUKUDA DENSHI MODEL FF SONIC UF-750XT by Fukuda Denshi USA, Inc. — Product Code IYN

K033209 is an FDA 510(k) premarket notification submitted by Fukuda Denshi USA, Inc. for the device "FUKUDA DENSHI MODEL FF SONIC UF-750XT". The FDA issued a decision of Substantially Equivalent on October 31, 2003. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Fukuda Denshi USA, Inc. has at least 10 other 510(k) clearances on record.