FDA 510(k)

齊姆8000

K 號：K190497 · 2019-11-20

決定日期2019-11-20

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

Ziehm 8000 is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm Imaging GmbH. It received FDA 510(k) clearance on 2019-11-20 under 510(k) number K190497. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ziehm 8000?

Ziehm 8000 is a medical device that received FDA 510(k) clearance on 2019-11-20. The listed applicant is Ziehm Imaging GmbH. The 510(k) number is K190497.

When did Ziehm 8000 receive FDA 510(k) clearance?

Ziehm 8000 received FDA 510(k) clearance on 2019-11-20, under 510(k) number K190497.

Who is the listed applicant for Ziehm 8000?

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

What is the FDA product code for Ziehm 8000?

The FDA product code for Ziehm 8000 is OWB.

其他以 Ziehm Imaging GmbH 為申請人之記錄

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相關器械（代碼：OWB）

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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