FDA 510(k)

ARTHUR

K 號：K260190 · 2026-06-18

決定日期2026-06-18

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

ARTHUR is the device name listed in this FDA 510(k) record. The listed applicant is ROPCA ApS. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K260190. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARTHUR?

ARTHUR is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is ROPCA ApS. The 510(k) number is K260190.

When did ARTHUR receive FDA 510(k) clearance?

ARTHUR received FDA 510(k) clearance on 2026-06-18, under 510(k) number K260190.

Who is the listed applicant for ARTHUR?

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

What is the FDA product code for ARTHUR?

The FDA product code for ARTHUR is IYO.

其他以 ROPCA ApS 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。

K260192DIANA

相關器械（代碼：IYO）

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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