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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K942163
Device Name WINNER SELF-TAKING HOME BLOOD PRESSURE KIT
Applicant
Winmed Instruments Mfg. Corp.
P.O. Box 5-33 Nan Kang
Taipei 11599,  TW
Applicant Contact BENSON TING
Correspondent
Winmed Instruments Mfg. Corp.
P.O. Box 5-33 Nan Kang
Taipei 11599,  TW
Correspondent Contact BENSON TING
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/04/1994
Decision Date 12/20/1994
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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