K093260 - AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM
(FDA 510(k) Clearance)

K093260 is an FDA 510(k) clearance for the AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM, a Apparatus, Nitric Oxide Delivery (Class II — Special Controls, product code MRN), submitted by International Biomedical, Ltd. (Austin, US). The FDA issued a Cleared decision on December 16, 2009, 58 days after receiving the submission on October 19, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5165.