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FDA 510(k)

電外科發生器（ES-100）；電外科發生器（ES-300）

K 號：K240975 · 2024-12-23

申請人Beijing Taktvoll Technology Co., Ltd.
決定日期2024-12-23
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

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Taktvoll Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K240975. 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 Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)?

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Beijing Taktvoll Technology Co., Ltd.. The 510(k) number is K240975.

When did Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) receive FDA 510(k) clearance?

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) received FDA 510(k) clearance on 2024-12-23, under 510(k) number K240975.

Who is the listed applicant for Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)?

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

What is the FDA product code for Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)?

The FDA product code for Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) is GEI.

相關臨床試驗

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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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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