510(k) K151978

EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control by Edan Instruments, Inc. — Product Code CHL

K151978 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control". The FDA issued a decision of Substantially Equivalent on July 15, 2016. 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. Edan Instruments, Inc. has at least 10 other 510(k) clearances on record.