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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 K172733
Device Name TD-1035 Thermometer
Applicant
TaiDoc Technology Corporation
B1-7F, No.127, Wugong 2nd Rd., Wugu District
New Taipei City,  TW 24888
Applicant Contact Sheena Song
Correspondent
TaiDoc Technology Corporation
B1-7F, No.127, Wugong 2nd Rd., Wugu District
New Taipei City,  TW 24888
Correspondent Contact Sheena Song
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/11/2017
Decision Date 10/22/2018
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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