510(k) K853018

MODEL 3000 OPTICATH COMPUTER by Oximetrix, Inc. — Product Code DXG

K853018 is an FDA 510(k) premarket notification submitted by Oximetrix, Inc. for the device "MODEL 3000 OPTICATH COMPUTER". The FDA issued a decision of Substantially Equivalent on January 13, 1986. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Oximetrix, Inc. has at least 10 other 510(k) clearances on record.