510(k) K123683

NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR by Aerocrine AB — Product Code MXA

K123683 is an FDA 510(k) premarket notification submitted by Aerocrine AB for the device "NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR". The FDA issued a decision of Substantially Equivalent on December 27, 2012. 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.