510(k) K233446

AMC Health CareConsole by Amc Health — Product Code MWI

K233446 is an FDA 510(k) premarket notification submitted by Amc Health for the device "AMC Health CareConsole". The FDA issued a decision of Substantially Equivalent on September 27, 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. Amc Health has at least 1 other 510(k) clearance on record.