FDA 510(k)

Evita (V800); Evita (V600)

Número K: K253647 · 2026-05-07

Data da decisão2026-05-07

Código do produtoCBK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Evita (V800); Evita (V600) is the device name listed in this FDA 510(k) record. The listed applicant is Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2026-05-07 under 510(k) number K253647. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Evita (V800); Evita (V600)?

Evita (V800); Evita (V600) is a medical device that received FDA 510(k) clearance on 2026-05-07. The listed applicant is Draegerwerk AG & CO Kgaa. The 510(k) number is K253647.

When did Evita (V800); Evita (V600) receive FDA 510(k) clearance?

Evita (V800); Evita (V600) received FDA 510(k) clearance on 2026-05-07, under 510(k) number K253647.

Who is the listed applicant for Evita (V800); Evita (V600)?

The FDA 510(k) record lists Draegerwerk AG & CO Kgaa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Evita (V800); Evita (V600)?

The FDA product code for Evita (V800); Evita (V600) is CBK.

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Fonte oficial

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