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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 K111974
Device Name ION HEALTH USB INSTA-SCAN THERMOMETER
Applicant
Taidoc Technology Corporation
3f,5f, #127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Applicant Contact TELING HSU
Correspondent
Taidoc Technology Corporation
3f,5f, #127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Correspondent Contact TELING HSU
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/12/2011
Decision Date 08/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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