510(k) K083697

FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M by Fukuda Denshi USA, Inc. — Product Code MHX

K083697 is an FDA 510(k) premarket notification submitted by Fukuda Denshi USA, Inc. for the device "FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M". The FDA issued a decision of Substantially Equivalent on March 19, 2009. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Fukuda Denshi USA, Inc. has at least 10 other 510(k) clearances on record.