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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 K872584
Device Name FORTEC MI-306, MI-327 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 JAMES LUK
Correspondent
Nam Tai , Ltd.
12/F. & 13/F., Century Centre
44-46 Hungt To Rd. Kwun Tong
Kowloon, Hong Kong,  HK
Correspondent Contact JAMES LUK
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/01/1987
Decision Date 07/27/1987
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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