FDA 510(k)

AEON 腹腔鏡器械

K 號：K192235 · 2019-10-11

決定日期2019-10-11

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

AEON Laparoscopic Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Lexington Medical, Inc.. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K192235. 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 AEON Laparoscopic Instruments?

AEON Laparoscopic Instruments is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Lexington Medical, Inc.. The 510(k) number is K192235.

When did AEON Laparoscopic Instruments receive FDA 510(k) clearance?

AEON Laparoscopic Instruments received FDA 510(k) clearance on 2019-10-11, under 510(k) number K192235.

Who is the listed applicant for AEON Laparoscopic Instruments?

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

What is the FDA product code for AEON Laparoscopic Instruments?

The FDA product code for AEON Laparoscopic Instruments is GEI.

其他以 Lexington Medical, Inc. 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：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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