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FDA 510(k)

ArtiSential 腹腔镜器械-电极

K号: K203580 · 2021-04-30

申请人Livsmed, Inc.
决定日期2021-04-30
产品代码GEI
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

ArtiSential Laparoscopic Instruments-Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Livsmed, Inc.. It received FDA 510(k) clearance on 2021-04-30 under 510(k) number K203580. 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 ArtiSential Laparoscopic Instruments-Electrodes?

ArtiSential Laparoscopic Instruments-Electrodes is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Livsmed, Inc.. The 510(k) number is K203580.

When did ArtiSential Laparoscopic Instruments-Electrodes receive FDA 510(k) clearance?

ArtiSential Laparoscopic Instruments-Electrodes received FDA 510(k) clearance on 2021-04-30, under 510(k) number K203580.

Who is the listed applicant for ArtiSential Laparoscopic Instruments-Electrodes?

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

What is the FDA product code for ArtiSential Laparoscopic Instruments-Electrodes?

The FDA product code for ArtiSential Laparoscopic Instruments-Electrodes is GEI.

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列明Livsmed, Inc.为申报人的其他记录

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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。

官方来源

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