FDA 510(k)

GO-PEN®

K号: K250262 · 2025-04-24

决定日期2025-04-24

产品代码FMF

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

GO-PEN® is the device name listed in this FDA 510(k) record. The listed applicant is Go-Pen Aps. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K250262. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GO-PEN®?

GO-PEN® is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Go-Pen Aps. The 510(k) number is K250262.

When did GO-PEN® receive FDA 510(k) clearance?

GO-PEN® received FDA 510(k) clearance on 2025-04-24, under 510(k) number K250262.

Who is the listed applicant for GO-PEN®?

The FDA 510(k) record lists Go-Pen Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GO-PEN®?

The FDA product code for GO-PEN® is FMF.

相关器械（代码：FMF）

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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