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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 K171901
Device Name uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Mindray Building, Keji 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, Keji 12th Road South,
Hi-tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Correspondent Contact Yanhong Bai
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CCK   DQA   DRS   DRT   DSI  
DSJ   DSK   DXG   DXN   FLL   MLD  
Date Received06/26/2017
Decision Date 11/15/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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