510(k) K133898

NIOX VERO AIRWAY INFLAMMATION MONITOR by Aerocrine AB — Product Code MXA

K133898 is an FDA 510(k) premarket notification submitted by Aerocrine AB for the device "NIOX VERO AIRWAY INFLAMMATION MONITOR". The FDA issued a decision of Substantially Equivalent on November 6, 2014. The device falls under product code MXA (System, Test, Breath Nitric Oxide), a Class II device regulated under 21 CFR 862.3080. Aerocrine AB has at least 5 other 510(k) clearances on record.