510(k) K033711

FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM by Fukuda Denshi USA, Inc. — Product Code MHX

K033711 is an FDA 510(k) premarket notification submitted by Fukuda Denshi USA, Inc. for the device "FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 3, 2004. 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.