FDA 510(k)

Eko Foundation Analysis Software with Transformers (EFAST)

Número K: K251494 · 2025-08-12

Data da decisão2025-08-12

Código do produtoDQD

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Eko Foundation Analysis Software with Transformers (EFAST) is the device name listed in this FDA 510(k) record. The listed applicant is Eko Health, Inc.. It received FDA 510(k) clearance on 2025-08-12 under 510(k) number K251494. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Eko Foundation Analysis Software with Transformers (EFAST)?

Eko Foundation Analysis Software with Transformers (EFAST) is a medical device that received FDA 510(k) clearance on 2025-08-12. The listed applicant is Eko Health, Inc.. The 510(k) number is K251494.

When did Eko Foundation Analysis Software with Transformers (EFAST) receive FDA 510(k) clearance?

Eko Foundation Analysis Software with Transformers (EFAST) received FDA 510(k) clearance on 2025-08-12, under 510(k) number K251494.

Who is the listed applicant for Eko Foundation Analysis Software with Transformers (EFAST)?

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

What is the FDA product code for Eko Foundation Analysis Software with Transformers (EFAST)?

The FDA product code for Eko Foundation Analysis Software with Transformers (EFAST) is DQD.

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