510(k) K150233

NIOX VERO Airway Inflammation Monitor by Aerocrine AB — Product Code MXA

K150233 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 February 26, 2015. 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.