FDA 510(k)

STarFix 设计师软件 C0265

K号: K231141 · 2023-09-08

决定日期2023-09-08

产品代码QRI

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决定实质等同

器械摘要

STarFix Designer Software C0265 is the device name listed in this FDA 510(k) record. The listed applicant is FHC, Inc.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K231141. The device is classified under product code QRI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the STarFix Designer Software C0265?

STarFix Designer Software C0265 is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is FHC, Inc.. The 510(k) number is K231141.

When did STarFix Designer Software C0265 receive FDA 510(k) clearance?

STarFix Designer Software C0265 received FDA 510(k) clearance on 2023-09-08, under 510(k) number K231141.

Who is the listed applicant for STarFix Designer Software C0265?

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 STarFix Designer Software C0265?

The FDA product code for STarFix Designer Software C0265 is QRI.

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。

K200169VFS1 双极电外科发生器 K183123microTargeting Guideline 4000 5.0 系统

官方来源

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器械摘要

常见问题

相关临床试验

列明FHC, Inc.为申报人的其他记录

官方来源