510(k) K884063

BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM by C.R. Bard, Inc. — Product Code CCE

K884063 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM". The FDA issued a decision of Substantially Equivalent on December 16, 1988. 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. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.