510(k) K243324

Masimo O3 Regional Oximeter by Masimo Corporation — Product Code MUD

K243324 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Masimo O3 Regional Oximeter". The FDA issued a decision of Substantially Equivalent on July 17, 2025. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Masimo Corporation has at least 10 other 510(k) clearances on record.