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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 K862200
Device Name FORTEC MI-100, BLOOD PRESSURE METER
Applicant
Fortec Electronic Corp./Nam Tai
855 Matheson Blvd. E. Unit 4
L4w 4l6
Mississauga, Ont.,  CA
Applicant Contact FRANK KASTENMACHER
Correspondent
Fortec Electronic Corp./Nam Tai
855 Matheson Blvd. E. Unit 4
L4w 4l6
Mississauga, Ont.,  CA
Correspondent Contact FRANK KASTENMACHER
Regulation Number870.1110
Classification Product Code
DSK  
Date Received06/10/1986
Decision Date 11/18/1986
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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