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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 K081788
Device Name INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200
Applicant
Innochips Technology Co., Ltd.
49 Candle Wood Way
Buena Park,  CA  90621
Applicant Contact BRANDON CHOI
Correspondent
Innochips Technology Co., Ltd.
49 Candle Wood Way
Buena Park,  CA  90621
Correspondent Contact BRANDON CHOI
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/24/2008
Decision Date 12/17/2008
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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