FDA 510(k)

LAP-iX

K 號：K200639 · 2021-09-29

決定日期2021-09-29

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

LAP-iX is the device name listed in this FDA 510(k) record. The listed applicant is Sejong Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-09-29 under 510(k) number K200639. 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 LAP-iX?

LAP-iX is a medical device that received FDA 510(k) clearance on 2021-09-29. The listed applicant is Sejong Medical Co., Ltd.. The 510(k) number is K200639.

When did LAP-iX receive FDA 510(k) clearance?

LAP-iX received FDA 510(k) clearance on 2021-09-29, under 510(k) number K200639.

Who is the listed applicant for LAP-iX?

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

What is the FDA product code for LAP-iX?

The FDA product code for LAP-iX is GEI.

其他以 Sejong Medical Co., Ltd. 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。

K253165LAP-iX2N K252985Laport K200638LAP-iX 吸引灌洗 K173108Smoklean K173111LAP-iX 吸引灌洗 K173112LAP-iX

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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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