FDA 510(k)

COOLIEF 冷射频套件高级版

K号: K203066 · 2020-12-22

决定日期2020-12-22

产品代码GXI

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决定实质等同

器械摘要

COOLIEF Cooled Radiofrequency Kit Advanced is the device name listed in this FDA 510(k) record. The listed applicant is Avanos Medical, Inc.. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K203066. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the COOLIEF Cooled Radiofrequency Kit Advanced?

COOLIEF Cooled Radiofrequency Kit Advanced is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Avanos Medical, Inc.. The 510(k) number is K203066.

When did COOLIEF Cooled Radiofrequency Kit Advanced receive FDA 510(k) clearance?

COOLIEF Cooled Radiofrequency Kit Advanced received FDA 510(k) clearance on 2020-12-22, under 510(k) number K203066.

Who is the listed applicant for COOLIEF Cooled Radiofrequency Kit Advanced?

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

What is the FDA product code for COOLIEF Cooled Radiofrequency Kit Advanced?

The FDA product code for COOLIEF Cooled Radiofrequency Kit Advanced is GXI.

列明Avanos Medical, Inc.为申报人的其他记录

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相关器械（代码：GXI）

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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官方来源

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