510(k) K181956

Masimo MightySat Rx Fingertip Pulse Oximeter by Masimo Corporation — Product Code DQA

K181956 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Masimo MightySat Rx Fingertip Pulse Oximeter". The FDA issued a decision of Substantially Equivalent on Jan 23, 2019. 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.