FDA 510(k)

UDE

Número K: K202292 · 2020-10-05

Data da decisão2020-10-05

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

UDE is the device name listed in this FDA 510(k) record. The listed applicant is Ebm Technologies, Inc.. It received FDA 510(k) clearance on 2020-10-05 under 510(k) number K202292. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the UDE?

UDE is a medical device that received FDA 510(k) clearance on 2020-10-05. The listed applicant is Ebm Technologies, Inc.. The 510(k) number is K202292.

When did UDE receive FDA 510(k) clearance?

UDE received FDA 510(k) clearance on 2020-10-05, under 510(k) number K202292.

Who is the listed applicant for UDE?

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

What is the FDA product code for UDE?

The FDA product code for UDE is LLZ.

Literatura relacionada no PubMed

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.

PMID: 42566800Safety, feasibility, and outcomes of deep brain stimulation in young children excluded from the FDA Humanitarian Device Exemption: analysis of the CHILD-DBS registry.Journal of neurosurgery. Pediatrics ()PMID: 42174919Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data.Studies in health technology and informatics ()PMID: 41938148Device failures and patient adverse events from EUS: 26-year FDA MAUDE analysis (2000-2025).Endoscopic ultrasound ()PMID: 40854178Health Professional Students' Knowledge About FDA Drug and Medical Device Regulation.Academic medicine : journal of the Association of American Medical Colleges ()

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