510(k) K895149

NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY by Shiley, Inc. — Product Code CCE

K895149 is an FDA 510(k) premarket notification submitted by Shiley, Inc. for the device "NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY". The FDA issued a decision of Substantially Equivalent on November 28, 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. Shiley, Inc. has at least 10 other 510(k) clearances on record.