FDA 510(k)

CSF-4 (CSF-4)

N.º K: K232445 · 2024-05-02

Fecha de decisión2024-05-02

Código de productoDPS

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

CSF-4 (CSF-4) is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacsense. It received FDA 510(k) clearance on 2024-05-02 under 510(k) number K232445. 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-4 (CSF-4)?

CSF-4 (CSF-4) is a medical device that received FDA 510(k) clearance on 2024-05-02. The listed applicant is Cardiacsense. The 510(k) number is K232445.

When did CSF-4 (CSF-4) receive FDA 510(k) clearance?

CSF-4 (CSF-4) received FDA 510(k) clearance on 2024-05-02, under 510(k) number K232445.

Who is the listed applicant for CSF-4 (CSF-4)?

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-4 (CSF-4)?

The FDA product code for CSF-4 (CSF-4) 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.

K221260CSF-3

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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.