FDA 510(k)

ラジオ周波数発生装置システム、Cura RF電極

K番号: K240758 · 2024-12-11

申請者Zhejiang Curaway Medical Technology Co., Ltd.

決定日2024-12-11

製品コードGEI

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Radiofrequency Generator System, Cura RF Electrode 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 2024-12-11 under 510(k) number K240758. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Radiofrequency Generator System, Cura RF Electrode?

Radiofrequency Generator System, Cura RF Electrode is a medical device that received FDA 510(k) clearance on 2024-12-11. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. The 510(k) number is K240758.

When did Radiofrequency Generator System, Cura RF Electrode receive FDA 510(k) clearance?

Radiofrequency Generator System, Cura RF Electrode received FDA 510(k) clearance on 2024-12-11, under 510(k) number K240758.

Who is the listed applicant for Radiofrequency Generator System, Cura RF Electrode?

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

What is the FDA product code for Radiofrequency Generator System, Cura RF Electrode?

The FDA product code for Radiofrequency Generator System, Cura RF Electrode is GEI.

申請者としてZhejiang Curaway Medical Technology Co., Ltd.を記載するその他の記録

K260517自動芯生検装置 K244018disposableバイオプシー針 K242322骨髄生検針 K241793自動芯生検装置/ 半自動芯生検装置/ 一次性同軸生検針 K232505静脈内ラジオ周波数発生器、静脈内ラジオ周波数カテーテル K222001不可逆電穿孔消融発生装置、不可逆電穿孔プローブ

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