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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 K170514
Device Name Central Monitoring System
Applicant
Guangdong Biolight Meditech Co., Ltd.
#2 Innovation First Rd.,
Technical Innovation Coast Hi-Tech Zone
Zhuhai,  CN 519085
Applicant Contact Jin Liang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.1025
Classification Product Code
MHX  
Date Received02/21/2017
Decision Date 05/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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