510(k) K223608

GEM Premier 7000 with IQM3 by Instrumentation Laboratory Company — Product Code CHL

K223608 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory Company for the device "GEM Premier 7000 with IQM3". The FDA issued a decision of Substantially Equivalent on August 10, 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. Instrumentation Laboratory Company has at least 10 other 510(k) clearances on record.