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

Source: https://www.keypedia.com/records/483/agilemd-inc/0b189633-d644-4726-857a-3d2e6ef69f73

> FDA 483 for AgileMD, Inc. on November 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AgileMD, Inc.
- Inspection Date: 2023-11-20
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

## Related Officers

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

Company: https://www.keypedia.com/companies/agilemd-inc/ecf3e3aa-dbe9-4a26-96f9-5a7f43d9c430

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