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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 K981337
Device Name DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834A
Applicant
Mesure Technology
26792 Via Alcala
Mission Viejo,  CA  92691 -3432
Applicant Contact PHIL ZULUETA
Correspondent
Mesure Technology
26792 Via Alcala
Mission Viejo,  CA  92691 -3432
Correspondent Contact PHIL ZULUETA
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/13/1998
Decision Date 09/30/1998
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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