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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Electronic, Clinical
510(k) Number K082192
Device Name INFRARED EAR THERMOMETER, MODEL ET-101A
Applicant
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
4TH FLOOR, B2 BUILDING
FENG-TAN-LU INDUSTRIAL ZONE
HANGZHOU, ZHEJIANG,  CN 310030
Applicant Contact REN YUNHUA
Correspondent
CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL
BLDG. 16, 321 KUANG FU RD,SEC2
HSINCHU,,  TW
Correspondent Contact TZU-WEI LI
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/04/2008
Decision Date 09/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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