FDA 510(k)

Evoblock, Perléon

N.º K: K243621 · 2025-04-22

SolicitanteEvoden Indústria Comércio Importação E Exportação

Fecha de decisión2025-04-22

Código de productoEBG

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Evoblock, Perléon is the device name listed in this FDA 510(k) record. The listed applicant is Evoden Indústria Comércio Importação E Exportação. It received FDA 510(k) clearance on 2025-04-22 under 510(k) number K243621. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Evoblock, Perléon?

Evoblock, Perléon is a medical device that received FDA 510(k) clearance on 2025-04-22. The listed applicant is Evoden Indústria Comércio Importação E Exportação. The 510(k) number is K243621.

When did Evoblock, Perléon receive FDA 510(k) clearance?

Evoblock, Perléon received FDA 510(k) clearance on 2025-04-22, under 510(k) number K243621.

Who is the listed applicant for Evoblock, Perléon?

The FDA 510(k) record lists Evoden Indústria Comércio Importação E Exportação as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Evoblock, Perléon?

The FDA product code for Evoblock, Perléon is EBG.

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Fuente oficial

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