510(k) K142291

GMX Series Medical Air/Oxygen Blender by Gentec (Shanghai) Corporation — Product Code BZR

K142291 is an FDA 510(k) premarket notification submitted by Gentec (Shanghai) Corporation for the device "GMX Series Medical Air/Oxygen Blender". The FDA issued a decision of Substantially Equivalent on May 19, 2015. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330.