FDA 510(k)

TOMTEC-ARENA

K 號：K201632 · 2020-08-14

決定日期2020-08-14

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

TOMTEC-ARENA is the device name listed in this FDA 510(k) record. The listed applicant is Tomtec Imaging Systems GmbH. It received FDA 510(k) clearance on 2020-08-14 under 510(k) number K201632. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TOMTEC-ARENA?

TOMTEC-ARENA is a medical device that received FDA 510(k) clearance on 2020-08-14. The listed applicant is Tomtec Imaging Systems GmbH. The 510(k) number is K201632.

When did TOMTEC-ARENA receive FDA 510(k) clearance?

TOMTEC-ARENA received FDA 510(k) clearance on 2020-08-14, under 510(k) number K201632.

Who is the listed applicant for TOMTEC-ARENA?

The FDA 510(k) record lists Tomtec Imaging Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOMTEC-ARENA?

The FDA product code for TOMTEC-ARENA is LLZ.

其他以 Tomtec Imaging Systems 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。

K213544TOMTEC-ARENA

相關器械（代碼：LLZ）

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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