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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 K132140
Device Name DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER
Applicant
Duteck Industrial Co., Ltd.
3f-2, # 26, 513 Lane
Jui-Kuang Rd.
Taipei,  TW 114
Applicant Contact JOSEPH CHEN
Correspondent
Duteck Industrial Co., Ltd.
3f-2, # 26, 513 Lane
Jui-Kuang Rd.
Taipei,  TW 114
Correspondent Contact JOSEPH CHEN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/11/2013
Decision Date 02/04/2014
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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