Evita V800, Evita V600
K-Number: K222024 · 2023-05-16
ApplicantDraegerwerk AG & CO Kgaa
Decision Date2023-05-16
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 2023-05-16 under approval number K222024. 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 2023-05-16. It is manufactured by Draegerwerk AG & CO Kgaa. The 510(k) number is K222024.
When was Evita V800, Evita V600 approved by the FDA?
Evita V800, Evita V600 received FDA 510(k) clearance on 2023-05-16, under approval number K222024.
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.
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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.