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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, network and communication, physiological monitors
510(k) Number K183238
Device Name BeneVision Central Monitoring System
Applicant
Shenzhen Mindray Bio-medical Electronics Co., LTD.
Mindray Building, Keji 12th Road South
Hi-tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Applicant Contact Yanhong Bai
Correspondent
Shenzhen Mindray Bio-medical Electronics Co., LTD.
Mindray Building, Keji 12th Road South
Hi-tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Correspondent Contact Yanhong Bai
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
DQA   DRQ   DRT   DSB   DXN  
MHX  
Date Received11/20/2018
Decision Date 03/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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