510(k) K190468

Nihon Kohden SVM-7200 Series Vital Signs Monitor by Nihon Kohden Corporation — Product Code MWI

K190468 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corporation for the device "Nihon Kohden SVM-7200 Series Vital Signs Monitor". The FDA issued a decision of Substantially Equivalent on May 28, 2019. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Nihon Kohden Corporation has at least 10 other 510(k) clearances on record.