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FDA 510(k)

OxiWear

K-Number: K233827 · 2024-08-28

ApplicantOxiwear, Inc.
Decision Date2024-08-28
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OxiWear is a medical device manufactured by Oxiwear, Inc.. It received FDA 510(k) clearance on 2024-08-28 under approval number K233827. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OxiWear?

OxiWear is a medical device that received FDA 510(k) clearance on 2024-08-28. It is manufactured by Oxiwear, Inc.. The 510(k) number is K233827.

When was OxiWear approved by the FDA?

OxiWear received FDA 510(k) clearance on 2024-08-28, under approval number K233827.

What company makes OxiWear?

OxiWear is manufactured by Oxiwear, Inc..

What is the FDA product code for OxiWear?

The FDA product code for OxiWear is DQA.

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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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