510(k) K082785

NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES by Nihon Kohden America, Inc. — Product Code MHX

K082785 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES". The FDA issued a decision of Substantially Equivalent on November 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.