510(k) K973367

ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM by Radiometer America, Inc. — Product Code CHL

K973367 is an FDA 510(k) premarket notification submitted by Radiometer America, Inc. for the device "ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 6, 1997. 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.