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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 K150632
Device Name Hypervisor IX Monitoring System
Applicant
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
MINDRAY BUILDING, KENJI 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, KENJI 12TH ROAD SOUTH,
HI-TECH INDUSTRIAL PARK, NANSHAN
SHENZHEN,  CN 518057
Correspondent Contact YANHONG BAI
Regulation Number870.2300
Classification Product Code
MSX  
Date Received03/11/2015
Decision Date 07/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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