FDA 510(k)

盧加軟件

K 號：K262045 · 2026-07-07

決定日期2026-07-07

產品代碼EZD

諮詢委員會GU

決定相當於

器材摘要

Luja Soft is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A.S.. It received FDA 510(k) clearance on 2026-07-07 under 510(k) number K262045. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Luja Soft?

Luja Soft is a medical device that received FDA 510(k) clearance on 2026-07-07. The listed applicant is Coloplast A.S.. The 510(k) number is K262045.

When did Luja Soft receive FDA 510(k) clearance?

Luja Soft received FDA 510(k) clearance on 2026-07-07, under 510(k) number K262045.

Who is the listed applicant for Luja Soft?

The FDA 510(k) record lists Coloplast A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Luja Soft?

The FDA product code for Luja Soft is EZD.

其他以 Coloplast A.S. 為申請人之記錄

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相關器械（代碼：EZD）

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官方來源

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