FDA 510(k)

Radiofrequency Generator System, Cura RF Electrode

Numéro K : K240758 · 2024-12-11

DemandeurZhejiang Curaway Medical Technology Co., Ltd.

Date de décision2024-12-11

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

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Source officielle

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