FDA 510(k)

维贝RF II

K号: K241535 · 2024-09-25

决定日期2024-09-25

产品代码GEI

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决定实质等同

器械摘要

Vybe RF II is the device name listed in this FDA 510(k) record. The listed applicant is ShenB Co., Ltd.. It received FDA 510(k) clearance on 2024-09-25 under 510(k) number K241535. 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 Vybe RF II?

Vybe RF II is a medical device that received FDA 510(k) clearance on 2024-09-25. The listed applicant is ShenB Co., Ltd.. The 510(k) number is K241535.

When did Vybe RF II receive FDA 510(k) clearance?

Vybe RF II received FDA 510(k) clearance on 2024-09-25, under 510(k) number K241535.

Who is the listed applicant for Vybe RF II?

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

What is the FDA product code for Vybe RF II?

The FDA product code for Vybe RF II is GEI.

列明ShenB 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。

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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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