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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 K872527
Device Name OMRON DIGITAL FEVER THERMOMETER MODEL MC-12B
Applicant
Omron Electronics, Inc.
One E. Commerce Dr.
Schaumburg,  IL  60173
Applicant Contact OISHI
Correspondent
Omron Electronics, Inc.
One E. Commerce Dr.
Schaumburg,  IL  60173
Correspondent Contact OISHI
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/25/1987
Decision Date 07/23/1987
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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