FDA 483 - AgileMD, Inc. - November 20, 2023

This document is a Premarket Notification 510(k) Review for AgileMD, Inc.'s eCARTv5 Clinical Deterioration Suite. Dated November 20, 2023, the review pertains to a traditional 510(k) submission (K233253) for a Class II medical device, specifically a Cardiac Monitor. The submission was received on September 28, 2023, with a due date of December 27, 2023.