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FDA 510(k)

encevis

K-Number: K171720 · 2018-04-19

ApplicantAit Austrian Institute of Technology GmbH
Decision Date2018-04-19
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

encevis is the device name listed in this FDA 510(k) record. The listed applicant is Ait Austrian Institute of Technology GmbH. It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K171720. 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 2018-04-19. The listed applicant is Ait Austrian Institute of Technology GmbH. The 510(k) number is K171720.

When did encevis receive FDA 510(k) clearance?

encevis received FDA 510(k) clearance on 2018-04-19, under 510(k) number K171720.

Who is the listed applicant for encevis?

The FDA 510(k) record lists Ait Austrian Institute of Technology GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for encevis?

The FDA product code for encevis is OMB.

Other records listing Ait Austrian Institute of Technology GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240993encevis (2.1)

Related Devices (Code: 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.

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