# FDA 483 - AgileMD, Inc. - June 20, 2024

Source: https://www.keypedia.com/records/483/agilemd-inc/656cae67-8617-4273-8b31-f781f455f9ff

> FDA 483 for AgileMD, Inc. on June 20, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: AgileMD, Inc.
- Inspection Date: 2024-06-20
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: The provided document is a Premarket Notification 510(k) Review for AgileMD, Inc.'s eCARTv5 Clinical Deterioration Suite. The reviewer recommended that the device is Substantially Equivalent (SESE). This document does not contain any FDA Form 483 inspectional observations.

## Related Documents

- [483 - 2024-05-17](https://www.keypedia.com/records/483/agilemd-inc/fbadc308-4562-403a-9a5c-15cf55948811)

## Related Officers

- [Matthew Beckwith](https://www.keypedia.com/people/matthew-beckwith/8271338b-47b2-42b9-a89c-ec456b39dd0e)

Company: https://www.keypedia.com/companies/agilemd-inc/cf635dbf-9fbb-4cd5-b4ef-f1f98b992902

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4