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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 K083185
Device Name CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1
Applicant
CADI SCIENTIFIC PTE.LTD
S65 W35739 PIPER ROAD
EAGLE,  WI  53119
Applicant Contact STEPHEN H GORSKI
Correspondent
CADI SCIENTIFIC PTE.LTD
S65 W35739 PIPER ROAD
EAGLE,  WI  53119
Correspondent Contact STEPHEN H GORSKI
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/29/2008
Decision Date 03/11/2009
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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