510(k) K081891

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

K081891 is an FDA 510(k) premarket notification submitted by Fukuda Denshi USA, Inc. for the device "FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on August 29, 2008. 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.