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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 K080192
Device Name HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)
Applicant
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
55 NORTHERN BLVD., SUITE 200
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN
Correspondent
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
55 NORTHERN BLVD., SUITE 200
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN
Regulation Number870.2300
Classification Product Code
MSX  
Date Received01/25/2008
Decision Date 04/03/2008
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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