510(k) K905530

PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM by Puritan Bennett Corp. — Product Code BYT

K905530 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM". The FDA issued a decision of Substantially Equivalent on March 1, 1991. The device falls under product code BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass)), a Class II device regulated under 21 CFR 868.5935. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.