510(k) K193481

AeroNOx 2.0 Nitric Oxide Titration & Monitoring System by International Biomedical — Product Code MRN

K193481 is an FDA 510(k) premarket notification submitted by International Biomedical for the device "AeroNOx 2.0 Nitric Oxide Titration & Monitoring System". The FDA issued a decision of Substantially Equivalent on March 10, 2020. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165. International Biomedical has at least 10 other 510(k) clearances on record.