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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 K843381
Device Name URI TX-100 MULTICHANNEL THERMOCOUPLE
Applicant
Uri Therm-X, Inc.
701 Devonshire Dr.
Champaign,  IL  61820
Applicant Contact EVERETTE C BURDETTE
Correspondent
Uri Therm-X, Inc.
701 Devonshire Dr.
Champaign,  IL  61820
Correspondent Contact EVERETTE C BURDETTE
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/28/1984
Decision Date 10/11/1984
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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