510(k) K252207

ABL90 FLEX PLUS System, safeCLINITUBES by Radiometer Medicals Aps — Product Code CHL

K252207 is an FDA 510(k) premarket notification submitted by Radiometer Medicals Aps for the device "ABL90 FLEX PLUS System, safeCLINITUBES". The FDA issued a decision of Substantially Equivalent on April 10, 2026. 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 Medicals Aps has at least 4 other 510(k) clearances on record.