FDA 510(k)

eCARTv5 Clinical Deterioration Suite (“eCART”)

Número K: K233253 · 2024-06-21

Data da decisão2024-06-21

Código do produtoQNL

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: QNL)

K260008Deterioration Index Version 2Epic Systems Corporation K233216CLEWICU SystemClew Medical , Ltd.K230842SignalHF (IM008)Implicity, Inc.K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical , Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.