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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 K013779
Device Name THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F
Applicant
Mesure Technology
34138 Courtney Terrace
Acton,  CA  93510
Applicant Contact PHIL ZULUETA
Correspondent
Mesure Technology
34138 Courtney Terrace
Acton,  CA  93510
Correspondent Contact PHIL ZULUETA
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/13/2001
Decision Date 03/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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