510(k) K142898

ABL800 FLEX with AQURE connectivity by Radiometer Medical Aps — Product Code CHL

K142898 is an FDA 510(k) premarket notification submitted by Radiometer Medical Aps for the device "ABL800 FLEX with AQURE connectivity". The FDA issued a decision of Substantially Equivalent on June 17, 2015. 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. Radiometer Medical Aps has at least 10 other 510(k) clearances on record.