510(k) K142244

CLEO PATIENT MONITOR by Infinium Medical — Product Code MWI

K142244 is an FDA 510(k) premarket notification submitted by Infinium Medical for the device "CLEO PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on February 6, 2015. 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.