510(k) K212876

Carescape SpO2 - Masimo by Masimo Corporation — Product Code DQA

K212876 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Carescape SpO2 - Masimo". The FDA issued a decision of Substantially Equivalent on October 8, 2021. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Masimo Corporation has at least 10 other 510(k) clearances on record.