FDA 510(k)

4DM

Número K: K260879 · 2026-09-10

Data da decisão2026-09-10

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

4DM is the device name listed in this FDA 510(k) record. The listed applicant is INVIA, LLC. It received FDA 510(k) clearance on 2026-09-10 under 510(k) number K260879. 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 4DM?

4DM is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is INVIA, LLC. The 510(k) number is K260879.

When did 4DM receive FDA 510(k) clearance?

4DM received FDA 510(k) clearance on 2026-09-10, under 510(k) number K260879.

Who is the listed applicant for 4DM?

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

What is the FDA product code for 4DM?

The FDA product code for 4DM is QIH.

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