510(k) K183116

Unity Network ID by GE Healthcare — Product Code MWI

K183116 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "Unity Network ID". The FDA issued a decision of Substantially Equivalent on Dec 6, 2018. 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 Healthcare has 168 other 510(k) clearances on record.