# FDA 483 - AgileMD, Inc. - May 17, 2024

Source: https://www.keypedia.com/records/483/agilemd-inc/fbadc308-4562-403a-9a5c-15cf55948811

> FDA 483 for AgileMD, Inc. on May 17, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AgileMD, Inc.
- Inspection Date: 2024-05-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: This document is a response from AgileMD, Inc., submitted by their regulatory counsel Hogan Lovells US LLP, to an FDA Additional Information Request concerning their 510(k) submission (K233253/S001) for the eCARTv5 Clinical Deterioration Suite. The submission addresses FDA's outstanding concerns to support clearance of the eCART device, which is a software product for automated risk stratification and early warning of patient deterioration.

## Related Documents

- [483 - 2024-06-20](https://www.keypedia.com/records/483/agilemd-inc/656cae67-8617-4273-8b31-f781f455f9ff)

## Related Officers

- [Kelliann Payne](https://www.keypedia.com/people/kelliann-payne/b14f7e48-4329-4342-a408-1dd3b058cd70)

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