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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K152739
Device Name Electronic Thermometer
Applicant
Guangdong Biolight Meditech Co., Ltd.
Innovation First Rd.
Technology Innovation Coast
Zhuhai,,  CN 519085
Applicant Contact JING LIANG
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact DIANA HONG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/23/2015
Decision Date 02/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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