FDA 510(k)

UNEEG EpiSight System

Número K: K253607 · 2026-06-11

Data da decisão2026-06-11

Código do produtoSEM

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

UNEEG EpiSight System is the device name listed in this FDA 510(k) record. The listed applicant is Uneeg Medical A/S. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K253607. The device is classified under product code SEM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the UNEEG EpiSight System?

UNEEG EpiSight System is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Uneeg Medical A/S. The 510(k) number is K253607.

When did UNEEG EpiSight System receive FDA 510(k) clearance?

UNEEG EpiSight System received FDA 510(k) clearance on 2026-06-11, under 510(k) number K253607.

Who is the listed applicant for UNEEG EpiSight System?

The FDA 510(k) record lists Uneeg Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNEEG EpiSight System?

The FDA product code for UNEEG EpiSight System is SEM.

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