FDA 510(k)

Ablação-fita

Número K: K222938 · 2023-09-12

Data da decisão2023-09-12

Código do produtoQTZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ablation-fit is the device name listed in this FDA 510(k) record. The listed applicant is R.A.W. S.R.L. It received FDA 510(k) clearance on 2023-09-12 under 510(k) number K222938. The device is classified under product code QTZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ablation-fit?

Ablation-fit is a medical device that received FDA 510(k) clearance on 2023-09-12. The listed applicant is R.A.W. S.R.L. The 510(k) number is K222938.

When did Ablation-fit receive FDA 510(k) clearance?

Ablation-fit received FDA 510(k) clearance on 2023-09-12, under 510(k) number K222938.

Who is the listed applicant for Ablation-fit?

The FDA 510(k) record lists R.A.W. S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ablation-fit?

The FDA product code for Ablation-fit is QTZ.

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Fonte oficial

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