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FDA 510(k)

AEON-C Stand Alone System

K-Number: K191477 · 2019-11-13

ApplicantHuvexel Co. , Ltd.
Decision Date2019-11-13
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 Huvexel Co. , Ltd.. It received FDA 510(k) clearance on 2019-11-13 under 510(k) number K191477. 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 2019-11-13. The listed applicant is Huvexel Co. , Ltd.. The 510(k) number is K191477.

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

AEON-C Stand Alone System received FDA 510(k) clearance on 2019-11-13, under 510(k) number K191477.

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

The FDA 510(k) record lists Huvexel Co. , Ltd. 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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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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