510(k) K890624

TISSUE OXYGEN MONITOR SYSTEM, MODEL II by Baxter Healthcare Corp — Product Code CCE

K890624 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "TISSUE OXYGEN MONITOR SYSTEM, MODEL II". The FDA issued a decision of Substantially Equivalent on December 22, 1989. The device falls under product code CCE (Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1200. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.