Encevis
K-Number: K211452 · 2021-12-02
Decision Date2021-12-02
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Encevis is a medical device manufactured by Austrian Institute of Technology GmbH. It received FDA 510(k) clearance on 2021-12-02 under approval number K211452. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Encevis?
Encevis is a medical device that received FDA 510(k) clearance on 2021-12-02. It is manufactured by Austrian Institute of Technology GmbH. The 510(k) number is K211452.
When was Encevis approved by the FDA?
Encevis received FDA 510(k) clearance on 2021-12-02, under approval number K211452.
What company makes Encevis?
Encevis is manufactured by Austrian Institute of Technology GmbH.
What is the FDA product code for Encevis?
The FDA product code for Encevis is OMB.
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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.