510(k) K201339

The NOxBOXi Nitric Oxide Delivery System by Praxair, Inc. — Product Code MRN

K201339 is an FDA 510(k) premarket notification submitted by Praxair, Inc. for the device "The NOxBOXi Nitric Oxide Delivery System". The FDA issued a decision of Substantially Equivalent on June 19, 2020. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165. Praxair, Inc. has at least 1 other 510(k) clearance on record.