FDA 510(k)

CDM Insights

Número K: K240680 · 2024-12-06

RequerenteOxford Brain Diagnostics, Ltd.

Data da decisão2024-12-06

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

CDM Insights is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Brain Diagnostics, Ltd.. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K240680. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CDM Insights?

CDM Insights is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Oxford Brain Diagnostics, Ltd.. The 510(k) number is K240680.

When did CDM Insights receive FDA 510(k) clearance?

CDM Insights received FDA 510(k) clearance on 2024-12-06, under 510(k) number K240680.

Who is the listed applicant for CDM Insights?

The FDA 510(k) record lists Oxford Brain Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CDM Insights?

The FDA product code for CDM Insights is QIH.

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