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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 K802607
Device Name TERPERATUR SENSING DEVICE
Applicant
BURDITT & CALKINS-SIEMENS-ELEMA
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/21/1980
Decision Date 11/19/1980
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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