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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K150352
Device Name V Series Monitoring System (including V12 and V21 Monitors)
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd.
South, Hi-Tech Industrial Park
Shenzhen,  CN 518057
Applicant Contact YANHONG BAI
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd.
South, Hi-Tech Industrial Park
Shenzhen,  CN 518057
Correspondent Contact YANHONG BAI
Regulation Number870.1025
Classification Product Code
MHX  
Date Received02/11/2015
Decision Date 09/02/2015
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
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