510(k) K073265

APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM by Apieron, Inc. — Product Code MXA

K073265 is an FDA 510(k) premarket notification submitted by Apieron, Inc. for the device "APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM". The FDA issued a decision of Substantially Equivalent on March 14, 2008. The device falls under product code MXA (System, Test, Breath Nitric Oxide), a Class II device regulated under 21 CFR 862.3080. Apieron, Inc. has at least 1 other 510(k) clearance on record.