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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 K193391
Device Name BeneVision Central Monitoring System
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd. S., Hi-Tech Industrial Park, Na
Shenzhen,  CN 518057
Applicant Contact Yanhong Bai
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd. S., Hi-Tech Industrial Park, Na
Shenzhen,  CN 518057
Correspondent Contact Yanhong Bai
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
DQA   DRQ   DRT   DSB   DXN  
MHX  
Date Received12/06/2019
Decision Date 05/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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