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FDA 510(k)

Aveli

K-Number: K212399 · 2021-10-22

ApplicantNc8, Inc.
Decision Date2021-10-22
Product CodeOUP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aveli is a medical device manufactured by Nc8, Inc.. It received FDA 510(k) clearance on 2021-10-22 under approval number K212399. The device is classified under product code OUP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aveli?

Aveli is a medical device that received FDA 510(k) clearance on 2021-10-22. It is manufactured by Nc8, Inc.. The 510(k) number is K212399.

When was Aveli approved by the FDA?

Aveli received FDA 510(k) clearance on 2021-10-22, under approval number K212399.

What company makes Aveli?

Aveli is manufactured by Nc8, Inc..

What is the FDA product code for Aveli?

The FDA product code for Aveli is OUP.

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Official Source

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

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