510(k) K193626

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

K193626 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Masimo Rad-97 Pulse CO-Oximeter and Accessories". The FDA issued a decision of Substantially Equivalent on Aug 10, 2020. 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.