FDA 510(k)

Deterioration Index Version 2

Número K: K260008 · 2026-09-18

Data da decisão2026-09-18

Código do produtoQNL

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Deterioration Index Version 2 is the device name listed in this FDA 510(k) record. The listed applicant is Epic Systems Corporation. It received FDA 510(k) clearance on 2026-09-18 under 510(k) number K260008. 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 Deterioration Index Version 2?

Deterioration Index Version 2 is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is Epic Systems Corporation. The 510(k) number is K260008.

When did Deterioration Index Version 2 receive FDA 510(k) clearance?

Deterioration Index Version 2 received FDA 510(k) clearance on 2026-09-18, under 510(k) number K260008.

Who is the listed applicant for Deterioration Index Version 2?

The FDA 510(k) record lists Epic Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deterioration Index Version 2?

The FDA product code for Deterioration Index Version 2 is QNL.

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