FDA 510(k)

LAP-iX

K号: K173112 · 2017-11-21

决定日期2017-11-21

产品代码GEI

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决定实质等同

器械摘要

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 2017-11-21 under 510(k) number K173112. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LAP-iX?

LAP-iX is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Sejong Medical Co., Ltd.. The 510(k) number is K173112.

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

LAP-iX received FDA 510(k) clearance on 2017-11-21, under 510(k) number K173112.

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.

列明Sejong Medical Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253165LAP-iX2N K252985Laport K200639LAP-iX K200638LAP-iX 吸引冲洗器 K173108Smoklean K173111LAP-iX 吸引冲洗器

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相关器械（代码：GEI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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