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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 K163256
Device Name Dual Mode Infrared Thermometer
Applicant
Intelliworks, LLC
4910 Wright Rd., Suite 120
Stafford,  TX  77477
Applicant Contact Dr. Jessica Leonardi
Correspondent
Intelliworks, LLC
4910 Wright Rd., Suite 120
Stafford,  TX  77477
Correspondent Contact Dr. Jessica Leonardi
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/21/2016
Decision Date 04/06/2017
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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