510(k) K212227

Philips MR Patient Care Portal by Invivo Corporation — Product Code MWI

K212227 is an FDA 510(k) premarket notification submitted by Invivo Corporation for the device "Philips MR Patient Care Portal". The FDA issued a decision of Substantially Equivalent on September 30, 2021. 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. Invivo Corporation has at least 10 other 510(k) clearances on record.