510(k) K050363

FUKUDA DENSHI MODEL UF-850XTD by Fukuda Denshi USA, Inc. — Product Code IYN

K050363 is an FDA 510(k) premarket notification submitted by Fukuda Denshi USA, Inc. for the device "FUKUDA DENSHI MODEL UF-850XTD". The FDA issued a decision of Substantially Equivalent on February 17, 2005. 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.