BeneVision Central Monitoring System

System, Network And Communication, Physiological Monitors

Shenzhen Mindray Bio-Medical Electronics Co., LTD

The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Benevision Central Monitoring System.

Pre-market Notification Details

Device IDK220058
510k NumberK220058
Device Name:BeneVision Central Monitoring System
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant Shenzhen Mindray Bio-Medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen,  CN 518057
ContactLi Lei
CorrespondentLi Lei
Shenzhen Mindray Bio-Medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen,  CN 518057
Product CodeMSX  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-06
Decision Date2022-06-01

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