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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 K861473
Device Name MODEL 63-654 THERMOMETER, ELECTRONICS, CLINICAL
Applicant
Radio Shack Div. Tandy Corp.
1100 One Tandy Center
Fort Worth,  TX  76102
Applicant Contact DAVID L GARNER
Correspondent
Radio Shack Div. Tandy Corp.
1100 One Tandy Center
Fort Worth,  TX  76102
Correspondent Contact DAVID L GARNER
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/22/1986
Decision Date 05/06/1986
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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