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FDA 510(k)

sterEOS工作站

K 號:K160914 · 2016-04-22

決定日期2016-04-22
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

sterEOS Workstation is the device name listed in this FDA 510(k) record. The listed applicant is Eos Imaging, Inc.. It received FDA 510(k) clearance on 2016-04-22 under 510(k) number K160914. 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 sterEOS Workstation?

sterEOS Workstation is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is Eos Imaging, Inc.. The 510(k) number is K160914.

When did sterEOS Workstation receive FDA 510(k) clearance?

sterEOS Workstation received FDA 510(k) clearance on 2016-04-22, under 510(k) number K160914.

Who is the listed applicant for sterEOS Workstation?

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

What is the FDA product code for sterEOS Workstation?

The FDA product code for sterEOS Workstation is LLZ.

相關臨床試驗

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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。

官方來源

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