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FDA 510(k)

Any-Etch

K 號:K260485 · 2026-05-14

決定日期2026-05-14
產品代碼KLE
諮詢委員會DE
決定相當於

器材摘要

Any-Etch is the device name listed in this FDA 510(k) record. The listed applicant is Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K260485. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Any-Etch?

Any-Etch is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K260485.

When did Any-Etch receive FDA 510(k) clearance?

Any-Etch received FDA 510(k) clearance on 2026-05-14, under 510(k) number K260485.

Who is the listed applicant for Any-Etch?

FDA 510(k) 紀錄將 Mediclus Co., Ltd. 列為申請人。這本身並不確立醫療器材製造商。

What is the FDA product code for Any-Etch?

The FDA product code for Any-Etch is KLE.

其他以 Mediclus Co., Ltd. 為申請人之記錄

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相關器械(代碼:KLE)

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官方來源

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