510(k) K072816

NIOX MINO by Aerocrine AB — Product Code MXA

K072816 is an FDA 510(k) premarket notification submitted by Aerocrine AB for the device "NIOX MINO". The FDA issued a decision of Substantially Equivalent on March 3, 2008. 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.