Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s

About This 510(k) Submission

K233038 is an FDA 510(k) clearance for the Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on March 8, 2024, 165 days after receiving the submission on September 25, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.