FDA 510(k)

射频发生器系统，Cura RF 电极

K号: K240758 · 2024-12-11

申请人Zhejiang Curaway Medical Technology Co., Ltd.

决定日期2024-12-11

产品代码GEI

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决定实质等同

器械摘要

Radiofrequency Generator System, Cura RF Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-11 under 510(k) number K240758. 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 Radiofrequency Generator System, Cura RF Electrode?

Radiofrequency Generator System, Cura RF Electrode is a medical device that received FDA 510(k) clearance on 2024-12-11. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. The 510(k) number is K240758.

When did Radiofrequency Generator System, Cura RF Electrode receive FDA 510(k) clearance?

Radiofrequency Generator System, Cura RF Electrode received FDA 510(k) clearance on 2024-12-11, under 510(k) number K240758.

Who is the listed applicant for Radiofrequency Generator System, Cura RF Electrode?

FDA 510(k)记录将浙江科瑞威医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Radiofrequency Generator System, Cura RF Electrode?

The FDA product code for Radiofrequency Generator System, Cura RF Electrode is GEI.

列明Zhejiang Curaway Medical Technology 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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官方来源

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