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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 K143267
Device Name TempTraq TT-100
Blue Spark Technologies Inc.
806 Sharon Drive, Suite G
Westlake,  OH  44145
Applicant Contact Jennifer Cartledge
REU Associates Inc.
409 Woodridge Dr.
Seneca,  SC  29672
Correspondent Contact Jennifer Cartledge
Regulation Number880.2910
Classification Product Code
Date Received11/13/2014
Decision Date 09/02/2015
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