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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 K120671
Device Name DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)
Applicant
Cotronic Technology Limited
West Of Zhou Shi Rd.
Xi Xiang St., Bao An Zone
Shen Zhen, Guang Dong,  CN 518126
Applicant Contact TANI MOK
Correspondent
Cotronic Technology Limited
West Of Zhou Shi Rd.
Xi Xiang St., Bao An Zone
Shen Zhen, Guang Dong,  CN 518126
Correspondent Contact TANI MOK
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/05/2012
Decision Date 05/17/2013
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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