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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 K072641
Device Name DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.
Applicant
Famidoc Technology Co., Ltd.
6/F,G Bldg. 14 Liuxian 1st
Rd 71 Block Baoan District
Shenzhen Guangdong,Pr,  CN
Applicant Contact STEELJIN
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/18/2007
Decision Date 11/01/2007
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
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