AgileMD, Inc.November 20, 2023

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

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Record Details

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.

Company: AgileMD, Inc.
Inspection Date: November 20, 2023
Product Type: Device
Office: Office of Medical Device and Radiological Health Operations
Person: Matthew Beckwith

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ID · 0b189633-d644-4726-857a-3d2e6ef69f73