510(k) K151080

Nihon Kohden CSM 1901 Bedside Monitor by Nihon Kohden — Product Code MHX

K151080 is an FDA 510(k) premarket notification submitted by Nihon Kohden for the device "Nihon Kohden CSM 1901 Bedside Monitor". The FDA issued a decision of Substantially Equivalent on November 5, 2015. 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 has at least 10 other 510(k) clearances on record.