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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K122221
Device Name NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
Applicant
TaiDoc Technology Corporation
3F,5F, No.127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Applicant Contact PINJUNG CHEN
Correspondent
TaiDoc Technology Corporation
3F,5F, No.127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Correspondent Contact PINJUNG CHEN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/25/2012
Decision Date 03/29/2013
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
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