510(k) K935784

PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM by Puritan-Bennett — Product Code BZD

K935784 is an FDA 510(k) premarket notification submitted by Puritan-Bennett for the device "PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM". The FDA issued a decision of Substantially Equivalent on July 13, 1994. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Puritan-Bennett has at least 3 other 510(k) clearances on record.