Decision Date2020-07-03
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Oxxiom is the device name listed in this FDA 510(k) record. The listed applicant is True Wearables, Inc.. It received FDA 510(k) clearance on 2020-07-03 under 510(k) number K200537. 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 Oxxiom?
Oxxiom is a medical device that received FDA 510(k) clearance on 2020-07-03. The listed applicant is True Wearables, Inc.. The 510(k) number is K200537.
When did Oxxiom receive FDA 510(k) clearance?
Oxxiom received FDA 510(k) clearance on 2020-07-03, under 510(k) number K200537.
Who is the listed applicant for Oxxiom?
The FDA 510(k) record lists True Wearables, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Oxxiom?
The FDA product code for Oxxiom 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.