FDA 510(k)

LoFric Origo

K 號：K250659 · 2025-09-26

決定日期2025-09-26

產品代碼EZD

諮詢委員會GU

決定相當於

器材摘要

LoFric Origo is the device name listed in this FDA 510(k) record. The listed applicant is Wellspect AB. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K250659. 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 LoFric Origo?

LoFric Origo is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Wellspect AB. The 510(k) number is K250659.

When did LoFric Origo receive FDA 510(k) clearance?

LoFric Origo received FDA 510(k) clearance on 2025-09-26, under 510(k) number K250659.

Who is the listed applicant for LoFric Origo?

FDA 510(k) 記錄將 Wellspect AB 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for LoFric Origo?

The FDA product code for LoFric Origo is EZD.

其他以 Wellspect AB 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261658LoFric Origo Pro Coudé K260999LoFric Elle Pro

相關器械（代碼：EZD）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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