FDA 510(k)

トマークビジョン、トマークプロフェッショナル、トマークQ、トマークプロフェッショナルQシェイプ

K番号: K201863 · 2021-02-18

決定日2021-02-18

製品コードNEU

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてSomatex Medical Technologies GmbHを記載するその他の記録

K182082トマークフォーエビバ，トマークフォーブレベラ K180443トマーク・ビジョン

公式ソース

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