510(k) K990401

FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER by Fukuda Denshi USA, Inc. — Product Code IYO

K990401 is an FDA 510(k) premarket notification submitted by Fukuda Denshi USA, Inc. for the device "FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER". The FDA issued a decision of Substantially Equivalent on October 15, 1999. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Fukuda Denshi USA, Inc. has at least 10 other 510(k) clearances on record.