510(k) K103737

OMNI II PATIENT MONITOR by Infinium Medical — Product Code MWI

K103737 is an FDA 510(k) premarket notification submitted by Infinium Medical for the device "OMNI II PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on June 2, 2011. 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.