FDA 510(k)

Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape

Número K: K201863 · 2021-02-18

RequerenteSomatex Medical Technologies GmbH

Data da decisão2021-02-18

Código do produtoNEU

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape is the device name listed in this FDA 510(k) record. The listed applicant is Somatex Medical Technologies GmbH. It received FDA 510(k) clearance on 2021-02-18 under 510(k) number K201863. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape?

Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape is a medical device that received FDA 510(k) clearance on 2021-02-18. The listed applicant is Somatex Medical Technologies GmbH. The 510(k) number is K201863.

When did Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape receive FDA 510(k) clearance?

Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape received FDA 510(k) clearance on 2021-02-18, under 510(k) number K201863.

Who is the listed applicant for Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape?

The FDA 510(k) record lists Somatex Medical Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape?

The FDA product code for Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape is NEU.

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Fonte oficial

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