FDA 510(k)

CSF-3

N.º K: K221260 · 2023-01-06

Fecha de decisión2023-01-06

Código de productoDPS

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Otros registros que enlistan a Cardiacsense como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K232445CSF-4 (CSF-4)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.