510(k) K101034

NIOX MINO MODEL 09-1000 by Aerocrine AB — Product Code MXA

K101034 is an FDA 510(k) premarket notification submitted by Aerocrine AB for the device "NIOX MINO MODEL 09-1000". The FDA issued a decision of Substantially Equivalent on September 2, 2010. 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.