510(k) K163459

Nihon Kohden Vital Sign Telemeter by Nihon Kohden Corporation — Product Code MHX

K163459 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corporation for the device "Nihon Kohden Vital Sign Telemeter". The FDA issued a decision of Substantially Equivalent on April 4, 2017. 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 Corporation has at least 10 other 510(k) clearances on record.