510(k) K080342

NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES by Nihon Kohden America, Inc. — Product Code MHX

K080342 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES". The FDA issued a decision of Substantially Equivalent on February 26, 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.