FDA 510(k)

CER-S

N.º K: K193177 · 2020-08-26

Fecha de decisión2020-08-26

Código de productoMLO

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. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K193177. The device is classified under product code MLO. 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 2020-08-26. The listed applicant is Cardiocalm. The 510(k) number is K193177.

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

CER-S received FDA 510(k) clearance on 2020-08-26, under 510(k) number K193177.

Who is the listed applicant for CER-S?

The FDA 510(k) record lists Cardiocalm 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 MLO.

Dispositivos relacionados (Código: MLO)

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Fuente oficial

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