510(k) K101286

SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 by Linde Healthcare AB — Product Code BZR

K101286 is an FDA 510(k) premarket notification submitted by Linde Healthcare AB for the device "SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04". The FDA issued a decision of Substantially Equivalent on October 20, 2011. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330.