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FDA 510(k)

AEON-C™ Stand Alone System

K-Number: K223140 · 2022-12-20

ApplicantDio Medical, Inc.
Decision Date2022-12-20
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AEON-C™ Stand Alone System is a medical device manufactured by Dio Medical, Inc.. It received FDA 510(k) clearance on 2022-12-20 under approval number K223140. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEON-C™ Stand Alone System?

AEON-C™ Stand Alone System is a medical device that received FDA 510(k) clearance on 2022-12-20. It is manufactured by Dio Medical, Inc.. The 510(k) number is K223140.

When was AEON-C™ Stand Alone System approved by the FDA?

AEON-C™ Stand Alone System received FDA 510(k) clearance on 2022-12-20, under approval number K223140.

What company makes AEON-C™ Stand Alone System?

AEON-C™ Stand Alone System is manufactured by Dio Medical, Inc..

What is the FDA product code for AEON-C™ Stand Alone System?

The FDA product code for AEON-C™ Stand Alone System is OVE.

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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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