FDA 510(k)

一次性微波治療天線

K 號：K201265 · 2021-07-23

申請人Nanjing Eco Microwave System Co., Ltd.

決定日期2021-07-23

產品代碼NEY

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 Microwave Therapeutic Antennas is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Eco Microwave System Co., Ltd.. It received FDA 510(k) clearance on 2021-07-23 under 510(k) number K201265. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Microwave Therapeutic Antennas?

Disposable Microwave Therapeutic Antennas is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Nanjing Eco Microwave System Co., Ltd.. The 510(k) number is K201265.

When did Disposable Microwave Therapeutic Antennas receive FDA 510(k) clearance?

Disposable Microwave Therapeutic Antennas received FDA 510(k) clearance on 2021-07-23, under 510(k) number K201265.

Who is the listed applicant for Disposable Microwave Therapeutic Antennas?

The FDA 510(k) record lists Nanjing Eco Microwave System Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Microwave Therapeutic Antennas?

The FDA product code for Disposable Microwave Therapeutic Antennas is NEY.

其他以 Nanjing Eco Microwave System 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。

K201262微波治療系統

相關器械（代碼：NEY）

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。

K252632微波消融設備Nanjing Dewen Medical Technology Co., Ltd.K253771可棄式微波消融天線 (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)Nanjing Devin Medical Technology Co., Ltd.K250718swiftPro系統 (SWF-SPS)；Swift系統 (SWF-SYS)Emblation Limited K241827微波消融發生器（KY-2000A、KY-2100A）Canyon Medical, Inc.K241825微波消融天線Canyon Medical, Inc.K240480IntelliBlate 麻醉微波消融系統控制台（IB-CON）；IntelliBlate 麻醉微波消融系統移動車（IB-CART）；IntelliBlate Ximitry 探頭組裝，13G x 15cm（IB-XPA-1315）；IntelliBlate Ximitry 探頭組裝，13G x 20cm（IB-XPA-1320）；IntelliBlate Ximitry 探頭組裝，13G x 27cm（IB-XPA-1327）Varian Medical Systems, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。