FDA 510(k)

AblatePal 射频消融系统

K号: K223135 · 2023-06-30

决定日期2023-06-30

产品代码GEI

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决定实质等同

器械摘要

AblatePal Radiofrequency Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Compal Electronics, Inc.. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K223135. 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 AblatePal Radiofrequency Ablation System?

AblatePal Radiofrequency Ablation System is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Compal Electronics, Inc.. The 510(k) number is K223135.

When did AblatePal Radiofrequency Ablation System receive FDA 510(k) clearance?

AblatePal Radiofrequency Ablation System received FDA 510(k) clearance on 2023-06-30, under 510(k) number K223135.

Who is the listed applicant for AblatePal Radiofrequency Ablation System?

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

What is the FDA product code for AblatePal Radiofrequency Ablation System?

The FDA product code for AblatePal Radiofrequency Ablation System is GEI.

列明Compal Electronics, Inc.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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