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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 the device name listed in this FDA 510(k) record. The listed applicant is Dio Medical, Inc.. It received FDA 510(k) clearance on 2022-12-20 under 510(k) 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. The listed applicant is Dio Medical, Inc.. The 510(k) number is K223140.

When did AEON-C™ Stand Alone System receive FDA 510(k) clearance?

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

Who is the listed applicant for AEON-C™ Stand Alone System?

The FDA 510(k) record lists Dio Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: OVE)

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.

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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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