510(k) K212161

Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories by Masimo Corporation — Product Code MWI

K212161 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories". The FDA issued a decision of Substantially Equivalent on March 6, 2023. 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 at least 10 other 510(k) clearances on record.