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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 K080981
Device Name EAR THERMOMETER, MODELS ST66 AND ST67
Applicant
Mesure Technology Co., Ltd.
7f,# 86,Sec.1, Kwang Fu Rd.
San Chung City,  TW 241
Applicant Contact JOHN CHEN
Correspondent
Mesure Technology Co., Ltd.
7f,# 86,Sec.1, Kwang Fu Rd.
San Chung City,  TW 241
Correspondent Contact JOHN CHEN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/07/2008
Decision Date 05/02/2008
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
Predetermined Change
Control Plan Authorized		 No
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