510(k) K182887

Masimo Rad-67 Pulse CO-Oximeter and Accessories by Masimo Corporation — Product Code DQA

K182887 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Masimo Rad-67 Pulse CO-Oximeter and Accessories". The FDA issued a decision of Substantially Equivalent on Mar 22, 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.