510(k) K183697

Masimo Rad-97 and Accessories by Masimo Corporation — Product Code MWI

K183697 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Masimo Rad-97 and Accessories". The FDA issued a decision of Substantially Equivalent on May 15, 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. Masimo Corporation has 86 other 510(k) clearances on record.