510(k) K220732

Mural Perinatal Surveillance by Ge Medical Systems Information Technologies, Inc. — Product Code HGM

K220732 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies, Inc. for the device "Mural Perinatal Surveillance". The FDA issued a decision of Substantially Equivalent on June 23, 2022. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Ge Medical Systems Information Technologies, Inc. has at least 10 other 510(k) clearances on record.