510(k) K992859

ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE by Radiometer America, Inc. — Product Code CHL

K992859 is an FDA 510(k) premarket notification submitted by Radiometer America, Inc. for the device "ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE". The FDA issued a decision of Substantially Equivalent on January 10, 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 America, Inc. has at least 10 other 510(k) clearances on record.