Aveli
K-Number: K212399 · 2021-10-22
ApplicantNc8, Inc.
Decision Date2021-10-22
Product CodeOUP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Aveli is the device name listed in this FDA 510(k) record. The listed applicant is Nc8, Inc.. It received FDA 510(k) clearance on 2021-10-22 under 510(k) 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. The listed applicant is Nc8, Inc.. The 510(k) number is K212399.
When did Aveli receive FDA 510(k) clearance?
Aveli received FDA 510(k) clearance on 2021-10-22, under 510(k) number K212399.
Who is the listed applicant for Aveli?
The FDA 510(k) record lists Nc8, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aveli?
The FDA product code for Aveli is OUP.
Related Devices (Code: OUP)
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.
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.