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FDA 510(k)

HEATfx 麻醉微波系統，HEATfx 麻醉微波系統推車，HEATfx 2.1 鈈，HEATfx 2.1 S 鈈，多點熱量感測器（MTS）

K 號：K200061 · 2020-07-09

申請人Galil Medical, Inc.
決定日期2020-07-09
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

HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) is the device name listed in this FDA 510(k) record. The listed applicant is Galil Medical, Inc.. It received FDA 510(k) clearance on 2020-07-09 under 510(k) number K200061. 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 HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)?

HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) is a medical device that received FDA 510(k) clearance on 2020-07-09. The listed applicant is Galil Medical, Inc.. The 510(k) number is K200061.

When did HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) receive FDA 510(k) clearance?

HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) received FDA 510(k) clearance on 2020-07-09, under 510(k) number K200061.

Who is the listed applicant for HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)?

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

What is the FDA product code for HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)?

The FDA product code for HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) is NEY.

相關臨床試驗

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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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