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FDA 510(k)

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

K-Number: K201863 · 2021-02-18

ApplicantSomatex Medical Technologies GmbH
Decision Date2021-02-18
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Somatex Medical Technologies GmbH. The 510(k) number is K201863.

When was Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape approved by the FDA?

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

What company makes Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape?

Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape is manufactured by Somatex Medical Technologies GmbH.

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.

Related Clinical Trials

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Other Devices by Somatex Medical Technologies GmbH

K182082Tumark for Eviva, Tumark for Brevera K180443Tumark Vision

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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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