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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 K150160
Device Name Temple Touch Pro (TTP) Non-invasive temperature monitoring system
Applicant
Medisim, Ltd.
G.G. Communications Center
Neve Ilan,  IL 90850
Applicant Contact Avi Ben Yaish
Correspondent
Medisim, Ltd.
G.G. Communications Center
Neve Ilan,  IL 90850
Correspondent Contact Avi Ben Yaish
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/23/2015
Decision Date 10/20/2015
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
Predetermined Change
Control Plan Authorized		 No
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