510(k) K201770

Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor by Masimo Corporation — Product Code DQA

K201770 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor". The FDA issued a decision of Substantially Equivalent on Sep 24, 2020. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Masimo Corporation has 86 other 510(k) clearances on record.