510(k) K211559

EasyStat 300 by Medica Corporation — Product Code CHL

K211559 is an FDA 510(k) premarket notification submitted by Medica Corporation for the device "EasyStat 300". The FDA issued a decision of Substantially Equivalent on January 27, 2023. The device falls under product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph), a Class II device regulated under 21 CFR 862.1120. Medica Corporation has at least 6 other 510(k) clearances on record.