FDA 510(k)

Tumark for Eviva, Tumark for Brevera

Número K: K182082 · 2018-10-31

RequerenteSomatex Medical Technologies GmbH

Data da decisão2018-10-31

Código do produtoNEU

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tumark for Eviva, Tumark for Brevera 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 2018-10-31 under 510(k) number K182082. 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 for Eviva, Tumark for Brevera?

Tumark for Eviva, Tumark for Brevera is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Somatex Medical Technologies GmbH. The 510(k) number is K182082.

When did Tumark for Eviva, Tumark for Brevera receive FDA 510(k) clearance?

Tumark for Eviva, Tumark for Brevera received FDA 510(k) clearance on 2018-10-31, under 510(k) number K182082.

Who is the listed applicant for Tumark for Eviva, Tumark for Brevera?

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 for Eviva, Tumark for Brevera?

The FDA product code for Tumark for Eviva, Tumark for Brevera is NEU.

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Outros registros que listam Somatex Medical Technologies GmbH como candidato(a)

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Fonte oficial

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