FDA 510(k)

Erbe ESU Model VIO® 3n with Accessories

Número K: K251108 · 2025-08-29

Data da decisão2025-08-29

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Erbe ESU Model VIO® 3n with Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K251108. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Erbe ESU Model VIO® 3n with Accessories?

Erbe ESU Model VIO® 3n with Accessories is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Erbe Elektromedizin GmbH. The 510(k) number is K251108.

When did Erbe ESU Model VIO® 3n with Accessories receive FDA 510(k) clearance?

Erbe ESU Model VIO® 3n with Accessories received FDA 510(k) clearance on 2025-08-29, under 510(k) number K251108.

Who is the listed applicant for Erbe ESU Model VIO® 3n with Accessories?

The FDA 510(k) record lists Erbe Elektromedizin GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Erbe ESU Model VIO® 3n with Accessories?

The FDA product code for Erbe ESU Model VIO® 3n with Accessories is GEI.

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Fonte oficial

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