FDA 510(k)

Aurora 抽吸器

K 號：K180372 · 2018-04-09

決定日期2018-04-09

產品代碼GEI

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

Aurora Evacuator is the device name listed in this FDA 510(k) record. The listed applicant is Rebound Therapeutics. It received FDA 510(k) clearance on 2018-04-09 under 510(k) number K180372. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aurora Evacuator?

Aurora Evacuator is a medical device that received FDA 510(k) clearance on 2018-04-09. The listed applicant is Rebound Therapeutics. The 510(k) number is K180372.

When did Aurora Evacuator receive FDA 510(k) clearance?

Aurora Evacuator received FDA 510(k) clearance on 2018-04-09, under 510(k) number K180372.

Who is the listed applicant for Aurora Evacuator?

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

What is the FDA product code for Aurora Evacuator?

The FDA product code for Aurora Evacuator is GEI.

其他以 Rebound Therapeutics 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。

K203745AURORA Evacuator +Coag K201840Aurora 外科內視鏡系統 (Surgiscope), Aurora 外科內視鏡系統 (圖像控制盒)K201637Aurora 抽吸器 + 凝固 K191861Aurora 外科內視鏡系統 K190075Aurora 抽吸器

相關器械（代碼：GEI）

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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