510(k) K171121

Masimo Root Monitoring System and Accessories by Masimo Corporation — Product Code MWI

K171121 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Masimo Root Monitoring System and Accessories". The FDA issued a decision of Substantially Equivalent on Nov 17, 2017. 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. Masimo Corporation has 86 other 510(k) clearances on record.