510(k) K963964

AVL COMPACT 3 PH/BLOOD GAS ANALYZER by Avl Scientific Corp. — Product Code CHL

K963964 is an FDA 510(k) premarket notification submitted by Avl Scientific Corp. for the device "AVL COMPACT 3 PH/BLOOD GAS ANALYZER". The FDA issued a decision of Substantially Equivalent on November 29, 1996. 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. Avl Scientific Corp. has at least 10 other 510(k) clearances on record.