FDA 510(k)

一次性電外科筆（MD1000）

K 號：K232460 · 2023-10-11

申請人Shenzhen Mecun Medical Supply Co., Ltd.

決定日期2023-10-11

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

Disposable electrosurgical pencil (MD1000) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mecun Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K232460. 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 Disposable electrosurgical pencil (MD1000)?

Disposable electrosurgical pencil (MD1000) is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is Shenzhen Mecun Medical Supply Co., Ltd.. The 510(k) number is K232460.

When did Disposable electrosurgical pencil (MD1000) receive FDA 510(k) clearance?

Disposable electrosurgical pencil (MD1000) received FDA 510(k) clearance on 2023-10-11, under 510(k) number K232460.

Who is the listed applicant for Disposable electrosurgical pencil (MD1000)?

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

What is the FDA product code for Disposable electrosurgical pencil (MD1000)?

The FDA product code for Disposable electrosurgical pencil (MD1000) is GEI.

其他以 Shenzhen Mecun Medical Supply Co., Ltd. 為申請人之記錄

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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