AVL OPTI PH/BLOOD GAS ANALYZER

AVL OPTI PH/BLOOD GAS ANALYZER is an FDA 510(k)-cleared medical device (K944089) manufactured by Avl Scientific Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 19, 1994. Regulation: 8.