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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Blood-Pressure
510(k) Number K873765
Device Name FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER
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 Number870.1110
Classification Product Code
DSK  
Date Received09/16/1987
Decision Date 10/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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