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FDA 510(k)

良好根PT

K 號:K252285 · 2025-09-19

決定日期2025-09-19
產品代碼KIF
諮詢委員會DE
決定相當於

器材摘要

Well-Root PT is the device name listed in this FDA 510(k) record. The listed applicant is Vericom Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K252285. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Well-Root PT?

Well-Root PT is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Vericom Co., Ltd.. The 510(k) number is K252285.

When did Well-Root PT receive FDA 510(k) clearance?

Well-Root PT received FDA 510(k) clearance on 2025-09-19, under 510(k) number K252285.

Who is the listed applicant for Well-Root PT?

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

What is the FDA product code for Well-Root PT?

The FDA product code for Well-Root PT is KIF.

其他以 Vericom Co., Ltd. 為申請人之記錄

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相關器械(代碼:KIF)

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官方來源

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