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FDA 510(k)

Thermi可重复使用非侵入性射频电极

K号: K171094 · 2017-05-08

决定日期2017-05-08
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

Thermi Reusable Non-invasive RF Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Thermgen, L.L.C. It received FDA 510(k) clearance on 2017-05-08 under 510(k) number K171094. 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 Thermi Reusable Non-invasive RF Electrode?

Thermi Reusable Non-invasive RF Electrode is a medical device that received FDA 510(k) clearance on 2017-05-08. The listed applicant is Thermgen, L.L.C. The 510(k) number is K171094.

When did Thermi Reusable Non-invasive RF Electrode receive FDA 510(k) clearance?

Thermi Reusable Non-invasive RF Electrode received FDA 510(k) clearance on 2017-05-08, under 510(k) number K171094.

Who is the listed applicant for Thermi Reusable Non-invasive RF Electrode?

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

What is the FDA product code for Thermi Reusable Non-invasive RF Electrode?

The FDA product code for Thermi Reusable Non-invasive RF Electrode is GEI.

相关临床试验

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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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