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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 K042013
Device Name DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F
Applicant
Mesure Technology Co., Ltd.
7f, 88, Sec. 1, Kwang Fu Rd.
San Chung City
Taipei Hsien,  TW R.O.C.
Applicant Contact JOHN CHEN
Correspondent
Mesure Technology Co., Ltd.
7f, 88, Sec. 1, Kwang Fu Rd.
San Chung City
Taipei Hsien,  TW R.O.C.
Correspondent Contact JOHN CHEN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/27/2004
Decision Date 09/08/2004
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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