FDA 510(k)

Tumark for Eviva，Tumark for Brevera

K 號：K182082 · 2018-10-31

決定日期2018-10-31

產品代碼NEU

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Somatex Medical Technologies GmbH 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K201863Tumark視覺, Tumark專業, Tumark Q, Tumark專業 Q-Shape K180443Tumark視覺設備

相關器械（代碼：NEU）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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