Submission Details
| 510(k) Number | K242728 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 10, 2024 |
| Decision Date | July 31, 2025 |
| Days to Decision | 324 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
BeneVision Central Monitoring System
Jul 2025
Decision
324d
Days
Class 2
Risk
About This 510(k) Submission
K242728 is an FDA 510(k) clearance for the BeneVision Central Monitoring System, a System, Network And Communication, Physiological Monitors (Class II — Special Controls, product code MSX), submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 31, 2025, 324 days after receiving the submission on September 10, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.
Device Classification
| Product Code | MSX — System, Network And Communication, Physiological Monitors |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2300 |
Manufacturer
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