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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 K220058
Device Name BeneVision Central Monitoring System
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd. S.
Hi-Tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Applicant Contact Li Lei
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd. S.
Hi-Tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Correspondent Contact Li Lei
Regulation Number870.2300
Classification Product Code
MSX  
Date Received01/06/2022
Decision Date 06/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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