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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 K031556
Device Name VIVATHERM THEMPERATURE MEASUREMENT SYSTEM
Applicant
Vivant Medical, Inc.
1916-A Old Middlefield Way
Mountain View,  CA  94043
Applicant Contact STEVEN KIM
Correspondent
Vivant Medical, Inc.
1916-A Old Middlefield Way
Mountain View,  CA  94043
Correspondent Contact STEVEN KIM
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/19/2003
Decision Date 06/23/2003
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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