FDA 510(k)

GO-PEN®

K 號：K250262 · 2025-04-24

決定日期2025-04-24

產品代碼FMF

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

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.

常見問題

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.

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官方來源

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