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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 K140681
Device Name BELTER INFRA-RED EAR THERMOMETER
Applicant
Shenzhen Belter Health Measurement and Analysis TE
702, 704 Block C, Tsinghua Unis Science Park
# 13 Langshan Rd. Hi-Tech Ind
Shenzhen, Guangdong,  CN 518057
Applicant Contact PANG MING
Correspondent
Shenzhen Belter Health Measurement and Analysis TE
702, 704 Block C, Tsinghua Unis Science Park
# 13 Langshan Rd. Hi-Tech Ind
Shenzhen, Guangdong,  CN 518057
Correspondent Contact PANG MING
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/18/2014
Decision Date 08/21/2014
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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