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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 (Without Arrhythmia Detection Or Alarms)
510(k) Number K153135
Device Name VITAL SIGNS MONITOR
Applicant
Guangdong Biolight Meditech Co., Ltd.
Innovation First Rd.
Technology Innovation Coast
Zhuhai,,  CN 519085
Applicant Contact Jin Liang
Correspondent
Mid-Link Conslting Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.2300
Classification Product Code
MWI  
Date Received10/30/2015
Decision Date 02/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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