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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 K131155
Device Name UGFT3; FHT7
Applicant
Medisim, Ltd.
G.G. Communications Center
Jerusalem,  IL 90850
Applicant Contact MOSHE YARDEN
Correspondent
Medisim, Ltd.
G.G. Communications Center
Jerusalem,  IL 90850
Correspondent Contact MOSHE YARDEN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/24/2013
Decision Date 08/28/2013
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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