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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 K122912
Model DT-11G/111G/K11B/K111B/111D/K111D/Y111D
Device Name DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
Applicant
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
bldg 2, baimiao ind. park
economic development zone
wuchang, hangzhou, zhejiang, 
Contact ahneo yang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/21/2012
Decision Date 11/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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