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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 K051422
Device Name DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE
Applicant
Medisim, Ltd.
Beit Hapa'Amon Box 124
20 Hata'As St.
Kfar Saba,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
Medisim, Ltd.
Beit Hapa'Amon Box 124
20 Hata'As St.
Kfar Saba,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/01/2005
Decision Date 09/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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