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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 K011254
Device Name EAR THERMOMETER, MODELS ST613C AND ST613F
Applicant
MESURE TECHNOLOGY
P.O. BOX 2249
MISSION VIEJO,  CA  92690
Applicant Contact PHIL ZULUETA
Correspondent
MESURE TECHNOLOGY
P.O. BOX 2249
MISSION VIEJO,  CA  92690
Correspondent Contact PHIL ZULUETA
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/24/2001
Decision Date 07/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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