510(k) K073550

PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION by Nihon Kohden America, Inc. — Product Code MHX

K073550 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION". The FDA issued a decision of Substantially Equivalent on March 28, 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. Nihon Kohden America, Inc. has at least 10 other 510(k) clearances on record.