510(k) K201764

Infinity Acute Care System (IACS) Monitoring Solution by Draeger Medical Systems, Inc. — Product Code MHX

K201764 is an FDA 510(k) premarket notification submitted by Draeger Medical Systems, Inc. for the device "Infinity Acute Care System (IACS) Monitoring Solution". The FDA issued a decision of Substantially Equivalent on December 9, 2021. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Draeger Medical Systems, Inc. has at least 10 other 510(k) clearances on record.