FDA 510(k)

Oxxiom

Número K: K200537 · 2020-07-03

Data da decisão2020-07-03

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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