510(k) K203790

GEM Premier 5000 by Instrumentation Laboratory CO — Product Code CHL

K203790 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "GEM Premier 5000". The FDA issued a decision of Substantially Equivalent on August 20, 2021. 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 CO has at least 10 other 510(k) clearances on record.