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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 K853317
Device Name FORTEC MI-305 & 306 DIGITAL THERMOMETER
Applicant
Nam Tai , Ltd.
12/F. & 13/F., Century Centre
44-46 Hungt To Rd. Kwun Tong
Kowloon, Hong Kong,  HK
Applicant Contact KENNETH MAK
Correspondent
Nam Tai , Ltd.
12/F. & 13/F., Century Centre
44-46 Hungt To Rd. Kwun Tong
Kowloon, Hong Kong,  HK
Correspondent Contact KENNETH MAK
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/07/1985
Decision Date 01/27/1986
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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