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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 K984553
Device Name TALKING DIGITAL THERMOMETER, MODEL KV-171
Applicant
K-Jump Health Co., Ltd.
720 Corporate Cir., Suite R
Golden,  CO  80401
Applicant Contact ROBERT J ZAPPA
Correspondent
K-Jump Health Co., Ltd.
720 Corporate Cir., Suite R
Golden,  CO  80401
Correspondent Contact ROBERT J ZAPPA
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/22/1998
Decision Date 01/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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