510(k) K895466

AVL MODEL 912 CO-OXYLITE by Avl Scientific Corp. — Product Code GLY

K895466 is an FDA 510(k) premarket notification submitted by Avl Scientific Corp. for the device "AVL MODEL 912 CO-OXYLITE". The FDA issued a decision of Substantially Equivalent on November 6, 1989. The device falls under product code GLY (Oximeter To Measure Hemoglobin), a Class II device regulated under 21 CFR 864.7500. Avl Scientific Corp. has at least 10 other 510(k) clearances on record.