510(k) K102376

NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 by Nihon Kohden Corp. — Product Code MHX

K102376 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corp. for the device "NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201". The FDA issued a decision of Substantially Equivalent on December 7, 2010. 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 Corp. has at least 10 other 510(k) clearances on record.