FDA 510(k)

ART.1-US

K 號：K253078 · 2026-05-14

決定日期2026-05-14

產品代碼MUJ

諮詢委員會RA

決定相當於

器材摘要

ART.1-US is the device name listed in this FDA 510(k) record. The listed applicant is Seetreat Pty, Ltd.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K253078. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ART.1-US?

ART.1-US is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Seetreat Pty, Ltd.. The 510(k) number is K253078.

When did ART.1-US receive FDA 510(k) clearance?

ART.1-US received FDA 510(k) clearance on 2026-05-14, under 510(k) number K253078.

Who is the listed applicant for ART.1-US?

The FDA 510(k) record lists Seetreat Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ART.1-US?

The FDA product code for ART.1-US is MUJ.

相關器械（代碼：MUJ）

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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