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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 K152402
FOIA Releasable 510(k) K152402
Device Name IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)
Applicant
Securus,Inc
100 Cummings Center, Suite 215f
Beverly,  MA  01915
Applicant Contact William J Gorman
Correspondent
Securus,Inc
100 Cummings Center, Suite 215f
Beverly,  MA  01915
Correspondent Contact William J Gorman
Regulation Number880.2910
Classification Product Code
FLL  
Subsequent Product Code
LHQ  
Date Received08/25/2015
Decision Date 03/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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