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FDA 510(k)

無線頻率等离子體外科系統；無線頻率等离子體外科電極

K 號：K221743 · 2023-09-07

申請人Jiangsu Bonss Medical Technology Co., Ltd.
決定日期2023-09-07
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

Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Bonss Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-07 under 510(k) number K221743. 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 Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes?

Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes is a medical device that received FDA 510(k) clearance on 2023-09-07. The listed applicant is Jiangsu Bonss Medical Technology Co., Ltd.. The 510(k) number is K221743.

When did Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes receive FDA 510(k) clearance?

Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes received FDA 510(k) clearance on 2023-09-07, under 510(k) number K221743.

Who is the listed applicant for Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes?

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

What is the FDA product code for Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes?

The FDA product code for Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes 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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