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FDA 510(k)

Oxy2Pro

K-Number: K222511 · 2023-11-21

ApplicantSouthmedic, Inc.
Decision Date2023-11-21
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Oxy2Pro is a medical device manufactured by Southmedic, Inc.. It received FDA 510(k) clearance on 2023-11-21 under approval number K222511. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oxy2Pro?

Oxy2Pro is a medical device that received FDA 510(k) clearance on 2023-11-21. It is manufactured by Southmedic, Inc.. The 510(k) number is K222511.

When was Oxy2Pro approved by the FDA?

Oxy2Pro received FDA 510(k) clearance on 2023-11-21, under approval number K222511.

What company makes Oxy2Pro?

Oxy2Pro is manufactured by Southmedic, Inc..

What is the FDA product code for Oxy2Pro?

The FDA product code for Oxy2Pro is CCK.

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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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