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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
Original Applicant
110 e. granada blvd
suite 209
ormond beach,  FL  32176
Original Contact claude berthoin
Regulation Number880.2910
Classification Product Code
Date Received08/08/2012
Decision Date 03/13/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
statement statement
Type Special
Reviewed by Third Party No
Combination Product No