encevis (2.1)
K-Number: K240993 · 2024-09-27
Decision Date2024-09-27
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
encevis (2.1) is a medical device manufactured by Ait Austrian Institute of Technology GmbH. It received FDA 510(k) clearance on 2024-09-27 under approval number K240993. 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 (2.1)?
encevis (2.1) is a medical device that received FDA 510(k) clearance on 2024-09-27. It is manufactured by Ait Austrian Institute of Technology GmbH. The 510(k) number is K240993.
When was encevis (2.1) approved by the FDA?
encevis (2.1) received FDA 510(k) clearance on 2024-09-27, under approval number K240993.
What company makes encevis (2.1)?
encevis (2.1) is manufactured by Ait Austrian Institute of Technology GmbH.
What is the FDA product code for encevis (2.1)?
The FDA product code for encevis (2.1) is OMB.
Other Devices by Ait Austrian Institute of Technology GmbH
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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.