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 IDK193391
510k NumberK193391
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 CodeDQA
Subsequent Product CodeDRQ
Subsequent Product CodeDRT
Subsequent Product CodeDSB
Subsequent Product CodeDXN
Subsequent Product CodeMHX
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-06
Decision Date2020-05-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06936415973537 K193391 000
06936415973520 K193391 000
06936415971588 K193391 000
06936415971571 K193391 000

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