510(k) K211286

Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger by Pall Corporation — Product Code CAH

K211286 is an FDA 510(k) premarket notification submitted by Pall Corporation for the device "Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger". The FDA issued a decision of Substantially Equivalent on November 16, 2021. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260.