FDA 510(k)

維奧利蒂

K 號：K201501 · 2021-02-23

決定日期2021-02-23

產品代碼OEB

諮詢委員會RA

決定相當於

器材摘要

Veolity is the device name listed in this FDA 510(k) record. The listed applicant is MeVis Medical Solutions AG. It received FDA 510(k) clearance on 2021-02-23 under 510(k) number K201501. The device is classified under product code OEB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Veolity?

Veolity is a medical device that received FDA 510(k) clearance on 2021-02-23. The listed applicant is MeVis Medical Solutions AG. The 510(k) number is K201501.

When did Veolity receive FDA 510(k) clearance?

Veolity received FDA 510(k) clearance on 2021-02-23, under 510(k) number K201501.

Who is the listed applicant for Veolity?

The FDA 510(k) record lists MeVis Medical Solutions AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Veolity?

The FDA product code for Veolity is OEB.

其他以 MeVis Medical Solutions AG 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。

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相關器械（代碼：OEB）

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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