510(k) K872278

SIEMENS O2-AIR MIXER 965 by Siemens Elema AB — Product Code BZR

K872278 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "SIEMENS O2-AIR MIXER 965". The FDA issued a decision of Substantially Equivalent on September 3, 1987. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Siemens Elema AB has at least 10 other 510(k) clearances on record.