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 IDK162607
510k NumberK162607
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
ContactYanhong Bai
CorrespondentYanhong Bai
Shenzhen Mindray Bio-Medical Electronics Co., Ltd Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen,  CN 518057
Product CodeMSX  
Subsequent Product CodeDRQ
Subsequent Product CodeMHX
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-19
Decision Date2017-04-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944904093444 K162607 000
06944904098364 K162607 000
06944904098371 K162607 000
06944904098388 K162607 000
06944904098814 K162607 000
06944904098821 K162607 000
06944904040776 K162607 000
06944904040783 K162607 000
06944904040790 K162607 000
06944904040806 K162607 000
06944904086859 K162607 000
06944904086866 K162607 000
06944904086873 K162607 000
06944904086880 K162607 000
06936415900809 K162607 000

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