510(k) K931112

MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI by Puritan Bennett Corp. — Product Code CBZ

K931112 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI". The FDA issued a decision of Substantially Equivalent on June 1, 1993. The device falls under product code CBZ (Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1170. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.