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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 K111703
Device Name INFRARED EAR THEROMETER
Applicant
Fudakang Industrial Co., Ltd.
205s Broadway Suite 718
Buena Park,  CA  90012
Applicant Contact DANIEL NAM
Correspondent
Fudakang Industrial Co., Ltd.
205s Broadway Suite 718
Buena Park,  CA  90012
Correspondent Contact DANIEL NAM
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/17/2011
Decision Date 03/29/2012
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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