FDA 510(k)

BeneVision Central Monitoring System

N.º K: K242728 · 2025-07-31

SolicitanteShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Fecha de decisión2025-07-31

Código de productoMSX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

BeneVision Central Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-07-31 under 510(k) number K242728. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BeneVision Central Monitoring System?

BeneVision Central Monitoring System is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K242728.

When did BeneVision Central Monitoring System receive FDA 510(k) clearance?

BeneVision Central Monitoring System received FDA 510(k) clearance on 2025-07-31, under 510(k) number K242728.

Who is the listed applicant for BeneVision Central Monitoring System?

The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BeneVision Central Monitoring System?

The FDA product code for BeneVision Central Monitoring System is MSX.

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Fuente oficial

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