510(k) K002290

ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) by Radiometer Medical A/S — Product Code CHL

K002290 is an FDA 510(k) premarket notification submitted by Radiometer Medical A/S for the device "ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)". The FDA issued a decision of Substantially Equivalent on September 13, 2000. 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 A/S has at least 1 other 510(k) clearance on record.