FDA 510(k)

CSF-3

Número K: K221260 · 2023-01-06

Data da decisão2023-01-06

Código do produtoDPS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

CSF-3 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacsense. It received FDA 510(k) clearance on 2023-01-06 under 510(k) number K221260. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CSF-3?

CSF-3 is a medical device that received FDA 510(k) clearance on 2023-01-06. The listed applicant is Cardiacsense. The 510(k) number is K221260.

When did CSF-3 receive FDA 510(k) clearance?

CSF-3 received FDA 510(k) clearance on 2023-01-06, under 510(k) number K221260.

Who is the listed applicant for CSF-3?

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

What is the FDA product code for CSF-3?

The FDA product code for CSF-3 is DPS.

Outros registros que listam Cardiacsense como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K232445CSF-4 (CSF-4)

Dispositivos Relacionados (Código: DPS)

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Fonte oficial

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