510(k) K993088

PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI by Puritan Bennett Corp. — Product Code CAW

K993088 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI". The FDA issued a decision of Substantially Equivalent on October 8, 1999. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.