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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 K874159
Device Name PATIENT TEMPERATURE MONITOR, MODEL 1000
Applicant
Sonodyne America, Ltd.
100-J Perimeter Park Dr.
Morrisville,  NC  27560
Applicant Contact GEORGE KING
Correspondent
Sonodyne America, Ltd.
100-J Perimeter Park Dr.
Morrisville,  NC  27560
Correspondent Contact GEORGE KING
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/13/1987
Decision Date 11/23/1987
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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