FDA 510(k)

CT-STOR

Número K: K201789 · 2021-09-20

Data da decisão2021-09-20

Código do produtoNDS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CT-STOR is the device name listed in this FDA 510(k) record. The listed applicant is Energy Delivery Solutions. It received FDA 510(k) clearance on 2021-09-20 under 510(k) number K201789. The device is classified under product code NDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CT-STOR?

CT-STOR is a medical device that received FDA 510(k) clearance on 2021-09-20. The listed applicant is Energy Delivery Solutions. The 510(k) number is K201789.

When did CT-STOR receive FDA 510(k) clearance?

CT-STOR received FDA 510(k) clearance on 2021-09-20, under 510(k) number K201789.

Who is the listed applicant for CT-STOR?

The FDA 510(k) record lists Energy Delivery Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT-STOR?

The FDA product code for CT-STOR is NDS.

Dispositivos Relacionados (Código: NDS)

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Fonte oficial

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