510(k) K201590

EMMA Capnograph by Masimo Corporation — Product Code CCK

K201590 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "EMMA Capnograph". The FDA issued a decision of Substantially Equivalent on March 29, 2021. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Masimo Corporation has at least 10 other 510(k) clearances on record.