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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name thermometer, electronic, clinical
510(k) Number K112703
Device Name SHAKER DIGITAL THERMOMETER
Original Applicant
MEASURE TECHNOLOGY CO. LTD.
7f, no 86, sec. 1, kwang fu rd
san chung city, taipei hsiang,  TW 241
Original Contact rack yu
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/16/2011
Decision Date 10/04/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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