510(k) K142467

IntelAir Nasal Airway Support System by Abeon Medical Corporation — Product Code CCK

K142467 is an FDA 510(k) premarket notification submitted by Abeon Medical Corporation for the device "IntelAir Nasal Airway Support System". The FDA issued a decision of Substantially Equivalent on November 24, 2014. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Abeon Medical Corporation has at least 1 other 510(k) clearance on record.