FDA 510(k)

Coolief Radiofrequency Generator (CRG) System

Número K: K192491 · 2020-02-21

Data da decisão2020-02-21

Código do produtoGXD

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Coolief Radiofrequency Generator (CRG) System 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 2020-02-21 under 510(k) number K192491. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Coolief Radiofrequency Generator (CRG) System?

Coolief Radiofrequency Generator (CRG) System is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Avanos Medical, Inc.. The 510(k) number is K192491.

When did Coolief Radiofrequency Generator (CRG) System receive FDA 510(k) clearance?

Coolief Radiofrequency Generator (CRG) System received FDA 510(k) clearance on 2020-02-21, under 510(k) number K192491.

Who is the listed applicant for Coolief Radiofrequency Generator (CRG) System?

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 Radiofrequency Generator (CRG) System?

The FDA product code for Coolief Radiofrequency Generator (CRG) System is GXD.

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Fonte oficial

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