FDA 510(k)

BeneVision Central Monitoring System

Numéro K : K242728 · 2025-07-31

DemandeurShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Date de décision2025-07-31

Code produitMSX

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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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