FDA 510(k)

Optum TeleHealth Application

Número K: K171406 · 2017-08-18

Data da decisão2017-08-18

Código do produtoDRG

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Optum TeleHealth Application is the device name listed in this FDA 510(k) record. The listed applicant is United Health Group, Inc.. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K171406. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Optum TeleHealth Application?

Optum TeleHealth Application is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is United Health Group, Inc.. The 510(k) number is K171406.

When did Optum TeleHealth Application receive FDA 510(k) clearance?

Optum TeleHealth Application received FDA 510(k) clearance on 2017-08-18, under 510(k) number K171406.

Who is the listed applicant for Optum TeleHealth Application?

The FDA 510(k) record lists United Health Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optum TeleHealth Application?

The FDA product code for Optum TeleHealth Application is DRG.

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