510(k) K943882

ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM by Radiometer America, Inc. — Product Code CHL

K943882 is an FDA 510(k) premarket notification submitted by Radiometer America, Inc. for the device "ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM". The FDA issued a decision of Substantially Equivalent on March 10, 1995. 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.