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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 K023956
Device Name THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F
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 Received11/27/2002
Decision Date 06/17/2004
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
Predetermined Change
Control Plan Authorized		 No
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