BeneVision Central Monitoring System
FDA 510(k) K242728 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
510(k) numberK242728
Submission
- Device name
- BeneVision Central Monitoring System
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Shenzhen, CN - Received
- September 10, 2024
- Decision date
- July 31, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K253654 | IntelliVue Measurement Rack 6000 (867317)MSX · Traditional | Philips Medizin Systeme Böblingen GmbH | 03/30/2026SE |
| K243270 | TigerConnect Alarm ManagementMSX · Traditional | Tigerconnect | 09/30/2025SE |
| K242750 | Central StationMSX · Traditional | Nihon Kohden Digital Health Solutions, LLC | 06/05/2025SE |
| K242842 | ANNE View, Central HubMSX · Traditional | Sibel Health, Inc. | 01/08/2025SE |
| K241397 | HinscopeMSX · Traditional | Hinlab Sas | 11/14/2024SE |
| K233834 | Infinity Gateway SuiteMSX · Traditional | Draeger Medical Systems, Inc. | 07/12/2024SE |
| K233418 | Biofourmis Everion+ (G2)MSX · Traditional | Biofourmis Singapore Pte., Ltd. | 05/09/2024SE |
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| K251250 | ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Multi Ultrasound System…IYN · Traditional | 09/05/2025SE |
Questions and answers
When was BeneVision Central Monitoring System cleared by the FDA?
BeneVision Central Monitoring System (K242728) received a 510(k) decision of Substantially Equivalent on July 31, 2025, 324 days after the submission was received.
What is the product code of K242728?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.