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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K153580
Device Name Central Monitoring System
Applicant
Guangdong Biolight Meditech Co., Ltd.
#2 Innovation First Rd., Technology 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 200237
Correspondent Contact Diana Hong
Regulation Number884.2740
Classification Product Code
HGM  
Date Received12/15/2015
Decision Date 09/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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