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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 K063542
Device Name WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F.
Applicant
MESURE TECHNOLOGY CO.,LTD.
7F,86, SEC.1,KWANG FU ROAD
SANCHUNG CITY, TAIPEI HSIEN,  TW 241
Applicant Contact JOHN CHEN
Correspondent
MESURE TECHNOLOGY CO.,LTD.
7F,86, SEC.1,KWANG FU ROAD
SANCHUNG CITY, TAIPEI HSIEN,  TW 241
Correspondent Contact JOHN CHEN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/24/2006
Decision Date 04/10/2007
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
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