510(k) K974784

AVL OPTI CRITICAL CARE ANALYZER by Avl Scientific Corp. — Product Code CEM

K974784 is an FDA 510(k) premarket notification submitted by Avl Scientific Corp. for the device "AVL OPTI CRITICAL CARE ANALYZER". The FDA issued a decision of Substantially Equivalent on February 24, 1998. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Avl Scientific Corp. has at least 10 other 510(k) clearances on record.