510(k) K231477

Infinity CentralStation Wide, Infinity M300, Infinity M300+ by Draeger Medical Systems, Inc. — Product Code MHX

K231477 is an FDA 510(k) premarket notification submitted by Draeger Medical Systems, Inc. for the device "Infinity CentralStation Wide, Infinity M300, Infinity M300+". The FDA issued a decision of Substantially Equivalent on October 17, 2023. 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.