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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 K853130
Device Name INTEGRATED DISPLAY TECHNOLOGY LTD.
Applicant
Integrated Display Technology, Ltd.
41, Man Yue St., Kaiser Estate
Block C, 9/F, Hung Hom,
Kowloon, Hong Kong,  HK
Applicant Contact SHIRLEY CHAN
Correspondent
Integrated Display Technology, Ltd.
41, Man Yue St., Kaiser Estate
Block C, 9/F, Hung Hom,
Kowloon, Hong Kong,  HK
Correspondent Contact SHIRLEY CHAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/26/1985
Decision Date 11/08/1985
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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