510(k) K233038

Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s by Edan Instruments, Inc. — Product Code MWI

K233038 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s". The FDA issued a decision of Substantially Equivalent on March 8, 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. Edan Instruments, Inc. has at least 10 other 510(k) clearances on record.