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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 the device name listed in this FDA 510(k) record. The listed applicant is Agilemd, Inc.. It received FDA 510(k) clearance on 2024-06-21 under 510(k) 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. The listed applicant is Agilemd, Inc.. The 510(k) number is K233253.

When did eCARTv5 Clinical Deterioration Suite (“eCART”) receive FDA 510(k) clearance?

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

Who is the listed applicant for eCARTv5 Clinical Deterioration Suite (“eCART”)?

The FDA 510(k) record lists Agilemd, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: QNL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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