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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 K090386
Device Name NON-INVASIVE INFRARED (NIR)
Applicant
Medisim, Ltd.
G.G. Communications Center
Neve Ilan,  IL 90850
Applicant Contact YEVGENIA LIBSTER
Correspondent
Medisim, Ltd.
G.G. Communications Center
Neve Ilan,  IL 90850
Correspondent Contact YEVGENIA LIBSTER
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/17/2009
Decision Date 05/28/2010
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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