FDA 510(k)

VFS1 双极电外科发生器

K号: K200169 · 2020-05-14

决定日期2020-05-14

产品代码GEI

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决定实质等同

器械摘要

VFS1 Bipolar Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is FHC, Inc.. It received FDA 510(k) clearance on 2020-05-14 under 510(k) number K200169. 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 VFS1 Bipolar Electrosurgical Generator?

VFS1 Bipolar Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is FHC, Inc.. The 510(k) number is K200169.

When did VFS1 Bipolar Electrosurgical Generator receive FDA 510(k) clearance?

VFS1 Bipolar Electrosurgical Generator received FDA 510(k) clearance on 2020-05-14, under 510(k) number K200169.

Who is the listed applicant for VFS1 Bipolar Electrosurgical Generator?

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

What is the FDA product code for VFS1 Bipolar Electrosurgical Generator?

The FDA product code for VFS1 Bipolar Electrosurgical Generator is GEI.

列明FHC, 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。

K231141STarFix 设计师软件 C0265 K183123microTargeting Guideline 4000 5.0 系统

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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