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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 K062445
Device Name MONITORING EAR THERMOMETER, MODEL BTM-D1A
Applicant
Rio Flexon Technology Co., Ltd.
15f,868-2, Jhong Jheng Rd.,
Jhonghe City Taipei County,  TW 235
Applicant Contact JEFF LIAO
Correspondent
Rio Flexon Technology Co., Ltd.
15f,868-2, Jhong Jheng Rd.,
Jhonghe City Taipei County,  TW 235
Correspondent Contact JEFF LIAO
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/22/2006
Decision Date 02/16/2007
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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