FDA 510(k)

CER-S

N.º K: K243312 · 2025-02-20

Fecha de decisión2025-02-20

Código de productoDQK

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

CER-S is the device name listed in this FDA 510(k) record. The listed applicant is Cardiocalm Srl. It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K243312. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CER-S?

CER-S is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is Cardiocalm Srl. The 510(k) number is K243312.

When did CER-S receive FDA 510(k) clearance?

CER-S received FDA 510(k) clearance on 2025-02-20, under 510(k) number K243312.

Who is the listed applicant for CER-S?

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

What is the FDA product code for CER-S?

The FDA product code for CER-S is DQK.

Otros registros que enlistan a Cardiocalm Srl 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.

K213861CER-S

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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.