510(k) K960518

THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM by Puritan Bennett Corp. — Product Code BZD

K960518 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM". The FDA issued a decision of Substantially Equivalent on May 9, 1996. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.