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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 K032434
Device Name CLINICAL ELECTRONIC THERMOMETER
Applicant
Cotronic Manufacturing
Jiu Wei, Xi Xiang
Bao An Zone
Shen Zhen,  CN
Applicant Contact SHINE WAN
Correspondent
Cotronic Manufacturing
Jiu Wei, Xi Xiang
Bao An Zone
Shen Zhen,  CN
Correspondent Contact SHINE WAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/06/2003
Decision Date 12/27/2004
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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