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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 K253170
Device Name uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd. S., Hi-Tech Industrial Park, Na
Shenzhen,  CN 518057
Applicant Contact Lei Li
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd. S., Hi-Tech Industrial Park, Na
Shenzhen,  CN 518057
Correspondent Contact Lei Li
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CCK   DQA   DRT   DSI   DSJ  
DSK   DXG   DXN   FLL   MLD  
Date Received09/26/2025
Decision Date 04/16/2026
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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