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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 K122412
Models 06400 SERIES, 06450 SERIES, 06480 SERIES, 06490 SERIES
Device Name VISIOFOCUS
Applicant
TECNIMED S.R.L.
110 e. granada blvd
suite 209
ormond beach,  FL  32176
Contact claude berthoin
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/08/2012
Decision Date 03/13/2013
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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