510(k) K232694

Central Monitoring System (MFM-CMS) by Edan Instruments, Inc. — Product Code MHX

K232694 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "Central Monitoring System (MFM-CMS)". The FDA issued a decision of Substantially Equivalent on February 5, 2024. 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. Edan Instruments, Inc. has at least 10 other 510(k) clearances on record.