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FDA 510(k)

eCARTv5 Clinical Deterioration Suite (“eCART”)

K-Number: K233253 · 2024-06-21

ApplicantAgilemd, Inc.
Decision Date2024-06-21
Product CodeQNL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

eCARTv5 Clinical Deterioration Suite (“eCART”) is a medical device manufactured by Agilemd, Inc.. It received FDA 510(k) clearance on 2024-06-21 under approval number K233253. The device is classified under product code QNL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eCARTv5 Clinical Deterioration Suite (“eCART”)?

eCARTv5 Clinical Deterioration Suite (“eCART”) is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by Agilemd, Inc.. The 510(k) number is K233253.

When was eCARTv5 Clinical Deterioration Suite (“eCART”) approved by the FDA?

eCARTv5 Clinical Deterioration Suite (“eCART”) received FDA 510(k) clearance on 2024-06-21, under approval number K233253.

What company makes eCARTv5 Clinical Deterioration Suite (“eCART”)?

eCARTv5 Clinical Deterioration Suite (“eCART”) is manufactured by Agilemd, Inc..

What is the FDA product code for eCARTv5 Clinical Deterioration Suite (“eCART”)?

The FDA product code for eCARTv5 Clinical Deterioration Suite (“eCART”) is QNL.

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Related PubMed Literature

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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