510(k) K905397

PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM by Puritan Bennett Corp. — Product Code CCE

K905397 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 14, 1991. 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. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.