FDA 510(k)

InMode射频Pro系统

K号: K210492 · 2021-07-12

决定日期2021-07-12

产品代码GEI

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决定实质等同

器械摘要

InMode RF Pro System is the device name listed in this FDA 510(k) record. The listed applicant is Inmode MD , Ltd.. It received FDA 510(k) clearance on 2021-07-12 under 510(k) number K210492. 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 InMode RF Pro System?

InMode RF Pro System is a medical device that received FDA 510(k) clearance on 2021-07-12. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K210492.

When did InMode RF Pro System receive FDA 510(k) clearance?

InMode RF Pro System received FDA 510(k) clearance on 2021-07-12, under 510(k) number K210492.

Who is the listed applicant for InMode RF Pro System?

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

What is the FDA product code for InMode RF Pro System?

The FDA product code for InMode RF Pro System is GEI.

列明Inmode MD , 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。

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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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