Decision Date2024-08-28
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
OxiWear is the device name listed in this FDA 510(k) record. The listed applicant is Oxiwear, Inc.. It received FDA 510(k) clearance on 2024-08-28 under 510(k) 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. The listed applicant is Oxiwear, Inc.. The 510(k) number is K233827.
When did OxiWear receive FDA 510(k) clearance?
OxiWear received FDA 510(k) clearance on 2024-08-28, under 510(k) number K233827.
Who is the listed applicant for OxiWear?
The FDA 510(k) record lists Oxiwear, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OxiWear?
The FDA product code for OxiWear is DQA.
Related Devices (Code: 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.