FDA 510(k)

不可逆電穿孔消融發生器，不可逆電穿孔探針

K 號：K222001 · 2023-06-08

申請人Zhejiang Curaway Medical Technology Co., Ltd.

決定日期2023-06-08

產品代碼OAB

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

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K222001. The device is classified under product code OAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe?

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. The 510(k) number is K222001.

When did Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe receive FDA 510(k) clearance?

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe received FDA 510(k) clearance on 2023-06-08, under 510(k) number K222001.

Who is the listed applicant for Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe?

FDA 510(k) 記錄將浙江庫瑞威醫療技術有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe?

The FDA product code for Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe is OAB.

其他以 Zhejiang Curaway Medical Technology Co., Ltd. 為申請人之記錄

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相關器械（代碼：OAB）

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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