510(k) K211561

INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) by Covidien, LLC — Product Code MUD

K211561 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)". The FDA issued a decision of Substantially Equivalent on December 5, 2021. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Covidien, LLC has at least 10 other 510(k) clearances on record.