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FDA 510(k)

AveCure BT 麻醉微波消融系統

K 號：K192406 · 2020-11-25

申請人Medwaves, Inc.
決定日期2020-11-25
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

AveCure BT Microwave Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Medwaves, Inc.. It received FDA 510(k) clearance on 2020-11-25 under 510(k) number K192406. 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 AveCure BT Microwave Ablation System?

AveCure BT Microwave Ablation System is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is Medwaves, Inc.. The 510(k) number is K192406.

When did AveCure BT Microwave Ablation System receive FDA 510(k) clearance?

AveCure BT Microwave Ablation System received FDA 510(k) clearance on 2020-11-25, under 510(k) number K192406.

Who is the listed applicant for AveCure BT Microwave Ablation System?

The FDA 510(k) record lists Medwaves, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AveCure BT Microwave Ablation System?

The FDA product code for AveCure BT Microwave Ablation System is NEY.

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：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 LimitedK241827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.

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