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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 K180148
Device Name ATS Thermal Imaging Probe, ATS Patient Interface Unit
Applicant
Securus Medical Group, Inc.
100 Cummings Center, Suite 215f
Beverly,  MA  01915
Applicant Contact William J. Gorman
Correspondent
Securus Medical Group, Inc.
100 Cummings Center, Suite 215f
Beverly,  MA  01915
Correspondent Contact William J. Gorman
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/19/2018
Decision Date 03/21/2018
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
Predetermined Change
Control Plan Authorized		 No
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