FDA 510(k)

E 激光器

K 號：K251899 · 2025-10-01

決定日期2025-10-01

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

E Blator is the device name listed in this FDA 510(k) record. The listed applicant is New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2025-10-01 under 510(k) number K251899. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the E Blator?

E Blator is a medical device that received FDA 510(k) clearance on 2025-10-01. The listed applicant is New Deantronics Taiwan , Ltd.. The 510(k) number is K251899.

When did E Blator receive FDA 510(k) clearance?

E Blator received FDA 510(k) clearance on 2025-10-01, under 510(k) number K251899.

Who is the listed applicant for E Blator?

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

What is the FDA product code for E Blator?

The FDA product code for E Blator is GEI.

其他以 New Deantronics Taiwan , Ltd. 為申請人之記錄

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相關器械（代碼：GEI）

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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