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FDA 510(k)

Artelon便利套件

K 號:K260317 · 2026-04-09

決定日期2026-04-09
產品代碼QWJ
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

Artelon Convenience Kits is the device name listed in this FDA 510(k) record. The listed applicant is International Life Sciences. It received FDA 510(k) clearance on 2026-04-09 under 510(k) number K260317. The device is classified under product code QWJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Artelon Convenience Kits?

Artelon Convenience Kits is a medical device that received FDA 510(k) clearance on 2026-04-09. The listed applicant is International Life Sciences. The 510(k) number is K260317.

When did Artelon Convenience Kits receive FDA 510(k) clearance?

Artelon Convenience Kits received FDA 510(k) clearance on 2026-04-09, under 510(k) number K260317.

Who is the listed applicant for Artelon Convenience Kits?

The FDA 510(k) record lists International Life Sciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Artelon Convenience Kits?

The FDA product code for Artelon Convenience Kits is QWJ.

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其他以 International Life Sciences 為申請人之記錄

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官方來源

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