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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 K881446
Device Name ORMON DIGITAL FEVER THERMOMETER MODEL MC-3B
Applicant
Ormon Electronics, Inc.
One E. Commerce Dr.
Schaumburg,  IL  60173
Correspondent
Ormon Electronics, Inc.
One E. Commerce Dr.
Schaumburg,  IL  60173
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/06/1988
Decision Date 07/20/1988
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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