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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 K122520
FOIA Releasable 510(k) K122520
Device Name DIGITAL THERMOMTER
Applicant
Taidoc Technology Corporation
6f, #127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Applicant Contact PINJUNG CHEN
Correspondent
Taidoc Technology Corporation
6f, #127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Correspondent Contact PINJUNG CHEN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/17/2012
Decision Date 02/05/2013
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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