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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 K100488
Device Name IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
Applicant
Shenzhen Dongdixin Technology Co., Ltd.
Estae Xilixiaobaimang
Nanshan District, Shenzhen,  CN 518108
Applicant Contact ZHIGANG ZHAO
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/19/2010
Decision Date 07/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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