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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 K843609
Device Name ELEX ELECTRONIC DIGITAL THERMOMETER
Applicant
Ewing Intl. , Ltd.
C1, 14th. Floor, Hoi Bun Bldg.
6 Winguip St.
Kwun Tong Kowloon, Hong K, 
Applicant Contact JACKSON CHU
Correspondent
Ewing Intl. , Ltd.
C1, 14th. Floor, Hoi Bun Bldg.
6 Winguip St.
Kwun Tong Kowloon, Hong K, 
Correspondent Contact JACKSON CHU
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/13/1984
Decision Date 01/25/1985
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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