510(k) K233810

Portrait VSM by Ge Medical Systems Information Technologies, Inc. — Product Code MWI

K233810 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies, Inc. for the device "Portrait VSM". The FDA issued a decision of Substantially Equivalent on April 25, 2024. 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. Ge Medical Systems Information Technologies, Inc. has at least 10 other 510(k) clearances on record.