510(k) K101052

OMNI III PATIENT MONITOR by Infinium Medical — Product Code MWI

K101052 is an FDA 510(k) premarket notification submitted by Infinium Medical for the device "OMNI III PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on August 11, 2010. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Infinium Medical has at least 6 other 510(k) clearances on record.