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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 K864089
Device Name HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA
Applicant
Hitachi Sales Corporation of America
P.O. Box 92232
Los Angeles,  CA  90009
Applicant Contact DAVID DAVIS
Correspondent
Hitachi Sales Corporation of America
P.O. Box 92232
Los Angeles,  CA  90009
Correspondent Contact DAVID DAVIS
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/21/1986
Decision Date 11/07/1986
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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