510(k) K203435

Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System by Nihon Kohden Corporation — Product Code MHX

K203435 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corporation for the device "Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System". The FDA issued a decision of Substantially Equivalent on July 16, 2021. 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.