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FDA 510(k)

Evita (V800); Evita (V600)

K-Number: K253647 · 2026-05-07

ApplicantDraegerwerk AG & CO Kgaa
Decision Date2026-05-07
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Draegerwerk AG & CO Kgaa. The 510(k) number is K253647.

When was Evita (V800); Evita (V600) approved by the FDA?

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

What company makes Evita (V800); Evita (V600)?

Evita (V800); Evita (V600) is manufactured by Draegerwerk AG & CO Kgaa.

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

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

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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