FDA 510(k)

COOLIEF Cooled Radiofrequency Kit Advanced

Número K: K203066 · 2020-12-22

Data da decisão2020-12-22

Código do produtoGXI

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

COOLIEF Cooled Radiofrequency Kit Advanced is the device name listed in this FDA 510(k) record. The listed applicant is Avanos Medical, Inc.. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K203066. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the COOLIEF Cooled Radiofrequency Kit Advanced?

COOLIEF Cooled Radiofrequency Kit Advanced is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Avanos Medical, Inc.. The 510(k) number is K203066.

When did COOLIEF Cooled Radiofrequency Kit Advanced receive FDA 510(k) clearance?

COOLIEF Cooled Radiofrequency Kit Advanced received FDA 510(k) clearance on 2020-12-22, under 510(k) number K203066.

Who is the listed applicant for COOLIEF Cooled Radiofrequency Kit Advanced?

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

What is the FDA product code for COOLIEF Cooled Radiofrequency Kit Advanced?

The FDA product code for COOLIEF Cooled Radiofrequency Kit Advanced is GXI.

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Fonte oficial

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