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FDA 510(k)

Oxxiom

K-Number: K200537 · 2020-07-03

ApplicantTrue Wearables, Inc.
Decision Date2020-07-03
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Oxxiom is a medical device manufactured by True Wearables, Inc.. It received FDA 510(k) clearance on 2020-07-03 under approval 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. It is manufactured by True Wearables, Inc.. The 510(k) number is K200537.

When was Oxxiom approved by the FDA?

Oxxiom received FDA 510(k) clearance on 2020-07-03, under approval number K200537.

What company makes Oxxiom?

Oxxiom is manufactured by True Wearables, Inc..

What is the FDA product code for Oxxiom?

The FDA product code for Oxxiom 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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