GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)

GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) is an FDA 510(k)-cleared medical device (K160412) manufactured by Instrumentation Laboratory CO. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 13, 2016. Regulation: 8.