510(k) K000746

FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX by Fukuda Denshi USA, Inc. — Product Code DSI

K000746 is an FDA 510(k) premarket notification submitted by Fukuda Denshi USA, Inc. for the device "FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX". The FDA issued a decision of Substantially Equivalent on April 7, 2000. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Fukuda Denshi USA, Inc. has at least 10 other 510(k) clearances on record.